Manufacturing Jobs

Associate Director QC Chemistry

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as an Associate Director QC Chemistry at a prestigious Fortune 500® company working in Irvine, CA. Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within. Job Title: Associate Director QC Chemistry Pay: $66.60 per hour Position Summary Provides guidance and technical expertise to QC Chemistry personnel in all areas of Quality Control functions, including finished product, raw material and stability. • Oversee the Chemistry laboratory activities, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products (including stability). • Oversee/approve investigations, ensuring they are being conducted according to approved procedures and that corrective and preventive actions are implemented and effective. • Ensure QC documentation is handled and archived according to the relevant approved procedures. • Oversee and ensure adequate maintenance of the laboratory equipment and systems and monitoring of the laboratory environment. • Establish and implements departmental policies and ensures compliance to cGMP, cGLP, FDA, and other applicable regulatory guidelines. Requirements • B.S. in Chemistry with a minimum of 10 years of work experiences in Pharmaceutical Chemistry Laboratory or related industry. • Minimum of 10-15 years of work experience in Pharmaceutical Chemistry Laboratory or related industry. Minimum of 5-6 years of supervisory and management experience. • In-depth knowledge of cGMPs, GLP, USP, BP and EP Chemistry test methods and requirements and FDA, EMEA and other regulatory guidelines. Thorough knowledge of Chemistry methods, lab equipment, and operation of LIMS system. • Excellent communication skills when communicating with senior management, colleagues, peers and management of other departments, etc. Possess good mentoring capabilities. • Demonstrates strong technical skills. • Strongly preferred experience in sterile/aseptic manufacturing operations and laboratory methods validation. • Builds strong working teams. * Mon-Fri 8am-5pm; Occasional Overtime and weekend hours may be required We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com . Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world. Kelly Services is an Equal Opportunity Employer Why Kelly ® ? With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today. About Kelly ® At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Associate Director QC Chemistry

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as an Associate Director QC Chemistry at a prestigious Fortune 500® company working in Irvine, CA. Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within. Job Title: Associate Director QC Chemistry Pay: $66.60 per hour Position Summary Provides guidance and technical expertise to QC Chemistry personnel in all areas of Quality Control functions, including finished product, raw material and stability. • Oversee the Chemistry laboratory activities, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products (including stability). • Oversee/approve investigations, ensuring they are being conducted according to approved procedures and that corrective and preventive actions are implemented and effective. • Ensure QC documentation is handled and archived according to the relevant approved procedures. • Oversee and ensure adequate maintenance of the laboratory equipment and systems and monitoring of the laboratory environment. • Establish and implements departmental policies and ensures compliance to cGMP, cGLP, FDA, and other applicable regulatory guidelines. Requirements *Experience with oversight with direct Chemistry Operations within commercial manufacturing • B.S. in Chemistry with a minimum of 10 years of work experiences in Pharmaceutical Chemistry Laboratory or related industry. • Minimum of 10-15 years of work experience in Pharmaceutical Chemistry Laboratory or related industry. Minimum of 5-6 years of supervisory and management experience. • In-depth knowledge of cGMPs, GLP, USP, BP and EP Chemistry test methods and requirements and FDA, EMEA and other regulatory guidelines. Thorough knowledge of Chemistry methods, lab equipment, and operation of LIMS system. • Excellent communication skills when communicating with senior management, colleagues, peers and management of other departments, etc. Possess good mentoring capabilities. • Demonstrates strong technical skills. • Strongly preferred experience in sterile/aseptic manufacturing operations and laboratory methods validation. • Builds strong working teams. * Mon-Fri 8am-5pm; Occasional Overtime and weekend hours may be required We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com . Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world. Kelly Services is an Equal Opportunity Employer Why Kelly ® ? With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today. About Kelly ® At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

REMOTE Sales Manager – North America – III-V Foundry Services

REMOTE Sales Manager – North America – III-V Foundry Services If you are a North American Sales Director with experience selling Silicon Carbide (SiC) Power Electronics, please read on! Job Title: Foundry Sales Director – North America – SiC Power Electronics Job Location: REMOTE – our U.S. HQ is located in Sunnyvale, CA Compensation: $150K – $250K+ (Depending on Experience) We are a foundry services company with a world-class III-V compound semiconductor manufacturing platform, headquartered in the port city of Xiamen in southeast coast of China. Our company is rapidly growing and is currently looking to expand our North American Sales team. Top Reasons to Work with Us 1) Competitive Compensation ($150K – $250K+ depending on experience) 2) Competitive Benefits package with health insurance 3) Career growth with a path to upper management! 4) Stable environment with a start-up like upside potential (our company falls under the umbrella of a public company with a $17 Billion USD market cap) What You Will Be Doing As a member of the global Sales team, the candidate will be responsible for the identification, business development, and securing of sales opportunities for compound semiconductor foundry services with Power Electronics accounts, namely with integrated device manufacturers (IDMs) and fabless semiconductor IC (integrated circuit) companies in the assigned territory (North America). The individual will be responsible for setting and meeting design win and sales revenue goals for the territory as well as maintain a Sales demand forecast. The position will report to the Sr. Director of North America and European Sales & Marketing. Candidate will work remotely with 25 – 50% travel within North America territory. – Drive demand-creation, business strategies, and sales activities with existing accounts and new prospects for silicon carbide (SiC) and gallium nitride on silicon (GaN-on-Si) process technologies at assigned focused customers in the Power Electronics market. – Generate, influence and close complex business opportunities for the assigned territory. – Set performance goals for the assigned accounts and implement measurement tools to monitor progress and success – Meet or exceed Sales goals for revenue, growth, gross margins, design-wins, and tape-outs including expense / budget control and business retention. – Report and maintain weekly, quarterly, and annual sales forecast, activities and performance plans. – Self-manage the sales process and initiate creative efforts to deliver results in line with the Sales Departments revenue goals and strategic priorities. – Be customer-focused and service oriented. – Communicate significant and emerging market trends and customer trends to Management – Maintain up-to-date profiles, organizational charts and business strategies for key accounts – Develop and deliver effective Sales & Marketing presentations of our company’s process technologies that address customers needs. – Build effective senior-level customer relationships to achieve Sales goals. – Collaborate and develop cohesive working relationships with cross-functional teams to support customers and develop effective business development strategies – Understand the customers current and future requirements, detect and identify market trends and communicate to internal departments. – Attend or participate in regional and national trade shows, industry conferences as needed. What You Need for this Position Bachelor’s Degree in Electrical Engineering or equivalent with 5+ years experience with the following: More Than 5 Years of experience and knowledge of: – SiC and/or GaN-on-Si process technologies and foundry service sales experience in the Power Electronics market with a proven track record. – Strong knowledge of high voltage MOSFETs, Schottky barrier diodes (SBD) electrical specs, high power AC/DC and DC/DC electronics circuits and applications for the power adapter, data center power supply, robotics, and automotive EV / HEV (hybrid / electric vehicle) markets. – Strong negotiation and communication skills. – Demonstrated effectiveness working with customers senior management and technical teams. – Independent, self-motivated, ability to work remotely from direct management. – Strong business planning skills with strategic mindset. – Frequent travel required: 25-50% within North America territory So, if you are a North American Sales Manager/Director with experience selling Silicon Carbide (SiC) Power Electronics, please apply today! or send an updated copy of your resume to Mike.Vandenbergh@CyberCoders.com for immediate consideration! – Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

High Power Laser Designer

High Power Laser Designer If you are a High Power Laser Designer with FP Laser design experience, please read on! Job Title: High Power Laser Designer – FP Lasers Job Location: Sunnyvale, CA or REMOTE w/ 30% – 40% travel to China Compensation: $150K – $200K+ DOE Backed by multibillion conglomerates, our company is focusing on laser technologies from research and development, custom design, fast prototyping, new product introduction and mass production. Our products including Edge-Emitting Lasers for telecom and consumer market, VCSELs and VCSEL arrays for Datacom and consumer market and Photo Detectors. Our affiliates provide in-house Epitaxy growth, a world-class manufacturing facility and excellent quality in high volume manufacturing. We are rapidly expanding and currently looking to hire an expert High-Power Laser Designer with experience with FP Laser or VCSEL design. Top Reasons to Work with Us 1) Competitive Compensation ($150K – $200K+ base salary plus bonus depending on experience and track record) 2) Competitive Benefits package with bonus and stock incentives! 3) Career growth with a path to management level, leading the local engineering team. 4) Stable environment with a start-up like upside potential (our company falls under the umbrella of a public company with a $17 Billion USD market cap) 5) The opportunity to work REMOTE with 30% – 40% travel to China. What You Will Be Doing – Design and develop epi structures of high-power lasers, specifically Fabry-Perot (FP), and VCSEL to achieve highest performances in terms of optical power, efficiency, wavelength stability, beam angle, modulation speed,reliability, etc. – Data analysis to build correlation between performance and designs. – Failure analysis of issues affecting functionality and performance. – Work closely with internal and external epitaxial engineer, integration engineer, packaging/testing for product development and quality improvement. What You Need for this Position M.S. or Ph.D. in Electrical Engineering or Physics, with 5+ years experience with the following: – Subject matter expert knowledge and substantial experience with current state-of-the-art laser diodes, including semiconductor device physics (gain, cavity design, heterostructure charge transport) and device reliability physics. – Nationally-recognized expertise in laser semiconductor design. – Experience with high power laser diode arrays, laser diode simulation software, laser diode current driver requirements, III-V semiconductor fabrication and materials technologies, and/or optoelectronic component packaging. – Expert communication, facilitation, and collaboration skills necessary to present, explain, and advise senior management and/or external sponsors. Desired Qualifications – High-Power Laser Design – Fabry-Perot (FP) or VCSEL design preferred – Expertise with 600nm – 800nm Diode Lasers – Work experience at Coherent, IPG Photonics, or similar company highly-preferred So, if you are a High Power Laser Designer with experience, please apply today! or send an updated copy of your resume to Mike.Vandenbergh@CyberCoders.com for immediate consideration! – Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Regional Sales Manager

Regional Sales Manager If you are a Regional Sales Manager with experience, please read on! Total Comp Earnings Year 1: Roughly a Base of $120-$140K + Variable Comp $55K – $65K… It all depends on experience as well. Car, phone, and travel covered! Top Reasons to Work with Us Headquartered in Houston, TX, we are a top global manufacturer and project engineering operations company in the Oil & Gas industry. What You Will Be Doing The Remote RSM in North Dakota will be responsible for winning new business and developing relationships with key customers and decision-makers in the pipeline installation and EPC (Engineering, Procurement and Construction) market. You will be assigned and managing an Account Executive, Sr. Account Executive and Program Account Manager. What You Need for this Position Required Skills:- Bachelor’s Degree – Oil & Gas Engineering/Manufacturing Industry Experience- 7+ years of experience selling highly engineered products- CRM (salesforce.com HIGHLY preferred)- Miller Heiman- Strategic Business Sales Methodologies- Cold Calling- Ability to travel regionally up to 50% Bonus Skills:- Pipeline or Oil & Gas Engineering, Procurement, Construction or Manufacturing sales experience- Miller Heiman certified or knowledge – Experience working with major exploration and production or midstream companies What’s In It for You – Base + Bonus/Commissions – Base of $120-$140K+ Variable Comp $55K – $65K It all depends on experience as well.- Travel Expenses Covered- Car/phone Allowances- 401K- PTO- Medical/ Dental/ Vision- Excellent company with amazing culture and people! So, if you are a Regional Sales Manager with experience, please apply today! – Applicants must be authorized to work in the U.S. CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Business Unit Controller

SUMMARY: This position will support the Corporate Controller to implement and maintain effective financial processes and procedures to ensure compliance to GAAP and government price/cost regulations. As a member of the leadership team reporting to the Engineered Products Division President, provide planning and analytic capability to support the Division achieve financial commitments.

DUTIES AND RESPONSIBILITIES:

• Works in tandem with the Corporate Controller and Division President to provide financial reporting and analysis for the multi-site operations.

• Manages the accountants at the Division’ s remote locations to provide oversight and guidance for accurate and efficient financial reporting.

• Support the Division President with various analysis and ad hoc projects including monthly operating reviews, quarterly board meetings, budget support, and monthly financial forecasts.

• In conjunction with Corporate accounting consolidations team, conduct division financial monthly close process with responsibility for GAAP compliant trial balances within the Division.

• Support all related financial audits of Division ledgers.

• Ensure accurate and effective inventory cost accounting procedures and processes.

• Deploy and monitor compliance with corporate disbursement authority policy and provide input to Corporate treasury function for cash management.

• Provide financial reporting and analysis for a multi-site division to include key performance indicators such as revenue, cost of sales, operating expenses and capital expenditures (includes assisting developing financial models and decision-making tools).

• Assist division management with the annual budget and rolling forecast process and provide recommendations and assistance to operating management.

• Assist with managing and supporting the financial integration activities of new business acquisitions. Provide management with monthly updates of integration progress as compared to integration budget.

• Working with the accounting function and division management, design and implement robust reporting of actual performance as compared to budget and rolling forecast to a department level and investigate variances to provide recommendations of improvement initiatives.

• In conjunction with Corporate and Division management develop a methodology for tracking cost reduction initiatives across the division.

• Assist in Developing models and provide ongoing financial support to division management as related to the business challenges and new business proposals.

• Keep abreast of vendor and customer payment issues to help manage cash expectations for the 13-week cash flow.

• Support all letters of credit and performance bond transactions including, but not limited to, monthly monitoring of any changes, extension of all existing bonds and creation of all new bonds.

• Other Ad hoc analysis and project work as assigned by the Corporate Controller or Division President.

• Develop and support intercompany policies including pricing, procedures, and reporting.

• Other duties as assigned.

SUPERVISORY RESPONSIBILITIES:

• Supervises the Sr. Accountant in each of the primary locations including Camarillo, Chatsworth, and Chula Vista.

QUALIFICATIONS:

• Bachelor’ s degree (B.A.) in Finance or Accounting required.

• Five to ten years related experience and/or training.

• CPA preferred.

• Experience or audit exposure within a manufacturing environment preferred.

• Experience in a defense industry with exposure to FAR, CAS desirable.

• Strong organizational, problem-solving, and analytical skills; able to manage priorities and workflow.

• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.

• Proven leadership and business acumen skills

• Commitment to excellence and high standards.

• Excellent written and verbal communication skills.

Email: dgavello@allianceresourcegroup.com

Associate Director-R&D

Job DetailsExperience 10 – 15 YearsAnnual Salary 130000.00-150000.00 USDWork Location Central Islip, New York, USADomain Pharmaceuticals/Biotechnology/Clinical ResearchJob DescriptionThe Associate Director, R&D (Solid Oral Dosage Form Product Transfer) position will lead all research and development (R&D) activities at co. NY . In this hands-on role the Associate Director, Technology Transfer, Solid Oral Dosage Forms (OSD), will be responsible for and provide technical leadership as related to technology transfer of product from company network of manufacturing facilities to another internal facility or to an external partner (e.g., CDMO/CRO). This position will report into the Senior Vice President and Head of R&D, North America. This position is based out of Long Island, NY. The job duties for this position include but are not limited to the following: Hands-on leadership of all R&D activities as related to product transfer of solid oral dosage form (OSD) products via the 505(j) pathway.Provide technical leadership as related to pre-formulation, formulation, manufacturing process development, technology transfer, established product support, analytical sciences with a focus on active pharmaceutical ingredient (API), excipients, intermediates and finished products. Single point accountability to lead a team of 1-3 scientists to implement technology transfer projects in a time bound manner to achieve business objectives.Manage scope, cost, time of projects as related to delivery against business objectives.Assess product characteristics and specific technologies associated with the products that are required to be transferred to ensure success at the receiving site.Assess equipment train associated with the approved products that are required to be transferred and use creative approaches to ensure product is successfully transferred with equipment train differences between transferring and receiving sites.Assess analytical methods associated with the approved products and proactively plan and implement analytical method transfer, verification or validation, as required. Assess strategy, plan and lead stability studies required to submit regulatory documents as related to qualification of second site.Work with Cipla global Regulatory Affairs to identify and draft strategy for product transfer; conduct relevant studies; provide and compile data for submission of regulatory approvals as related to qualification of second site.Work with Cipla global Supply Chain to proactively identify and troubleshoot supply chain topics to meet product transfer business objectives.Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to line functions. Maintain effective and pro-active communication and coordination of activities and deliverables with multi-functional stakeholders across geographical locations.Maintain effective working relationship and act as single-point technical contact for contract research organizations (CROs) and/or contract development and manufacturing organizations (CDMOs). Collaborate with project management (PM) function to lead execution of activities against approved plan.Train staff, peers and junior staff members on new techniques. TYPICAL DAY-TO-DAY ACTIVITIES Product transferTechnology transferTransferability assessmentEquipment train assessmentAnalytical method assessmentConsultation with supply chainR&D activities such as pre-formulation, formulation, process development or analytical method developmentTechnical troubleshootingProcess validationsMethod verificationsMethod validationsLeading activities at CROs and CMOsStability study managementDrafting dossier supportive documentsDrafting and responding to relevant requests from the US FDA or EU authoritiesTechnical ManagementFunctional Group Management EDUCATION AND EXPERIENCE Doctorate in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.Successful candidate may have specific background in Formulation and Process Development of solid oral dosage forms (OSD e.g., Tablets, Capsules etc.).Minimum 10 years of industry experience with demonstrated expertise in relevant area is required.In-depth understanding of physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must.In-depth understanding of various pre-formulation and formulation studies including excipient compatibility, forced degradation studies and unit steps in formulation manufacture is a must.In-depth understanding of pilot-scale and manufacturing-scale equipment is a must.Experience with process analytical technologies (PAT) is a plus.Experience with Analytical Sciences is a plus. PROFESSIONAL COMPETENCIES AND TECHNICAL SKILLSMust possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.Strong command over written and verbal English is a must. Past publication experience is a must.Must be able to work under minimal supervision and able to work independently and in a team environment.Must be able to exercise appropriate professional judgment on matters of significance.Must be proficient in computer skills and software applications such as Microsoft Office tools.Knowledge of statistical packages is a plus.Must communicate clearly and concisely across levels, both orally and in written. OTHER JOB INFORMATION Relocation negotiable.Employment sponsorship negotiable.No remote work available.Must be willing to work some weekends based on a relevant business need, if required.

Associate Director of Research & Development

REJECTAssociate Director of Research & Development Pharmaceuticals/Biotechnology/Clinical ResearchCentral Islip, New York, USAClient DetailsLEADING ARMACEUTICAL COMPANY In the last 80+ years, CO. has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. CO. is a fast-growing pharmaceutical company which the view to preserve our strong legacy and carve out a stronger future, we articulated our 2022 winning aspiration to double the number of patients we serve and hence double the impact we create as a global pharmaceutical company. Job DetailsExperience 10 – 15 YearsAnnual Salary 130000.00-150000.00 USDWork Location Central Islip, New York, USADomain Pharmaceuticals/Biotechnology/Clinical ResearchNO H1B employment sponsorship. Due to the amount of time required with H-1B transfer petitions and other related activities, it is our preference to not provide employment sponsorship. Please request the recruiters to provide resumes of candidates who do not require employment sponsorship. Thanks. Please find below the difference between the two Associate Director R&D Scientist roles. One position is to oversee the R&D team and activities for the Cipla New York (InvaGen Pharmaceuticals, Inc.) business unit. The other position is to oversee the R&D team and activities for the Cipla USA Exelan business unit which will also be located at the Cipla New York site.Other informations Both positions will report to the SVP of R&D.PhD is mandatory. JOB DESCRIPTION The Associate Director, R&D position will lead all research and development (R&D) activities at co. NY Pharmaceuticals Inc. In this role the Associate Director will lead a team of scientists comprised of formulation, process development, technology transfer and analytical sciences. This position will report into the Senior Vice President and Head of R&D, North America. This position is based out of Long Island, NY. The job duties for this position include but are not limited to the following: · Lead all R&D activities as related to development and registration of products via 505(b)(1), 505(b)(2) and 505(j) pathways.· Lead a team of scientists comprised of pre-formulation, formulation, manufacturing process development, technology transfer, established product support, analytical sciences with a focus on active pharmaceutical ingredient (API), excipients, intermediates and finished products.· Lead internal pipeline projects and collaborations with development partners (strategic development partners, CROs, CDMOs etc.).· Manage scope, cost, time of projects as related to delivery against business objectives.· Operate as the subject matter expert (SME) on pre-formulation and formulation, process development and technology transfer or analytical sciences as applied to development, characterization, process analytical technologies (PAT) and incorporation of active pharmaceutical ingredients (APIs), excipients, packaging material and devices to develop finished products. Products may range from internal product development projects, products that are commercialized, products that are in-licensed from external entity or products that are co-developed with a development partner. · Conduct API, excipient, packaging characterization; excipient compatibility and forced degradation studies. Recommend stage appropriate acceptance criteria for vendor and regulatory specifications. Utilize relevant theoretical modeling and statistical tools, as required.· Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE). Recommend stage appropriate acceptance criteria. Utilize PAT where feasible. Utilize relevant statistical tools, as required.· Review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction. Develop and implement strategies to control related substances, where applicable.· Work with relevant cross-functional stakeholders (e.g., Commercial Operations, Quality Control, Quality Assurance etc.) on scale-up and technology transfer of processes from R&D to commercial functions.· Lead and/or participate in activities related to process development, process verification/qualification, process pre-validation, process validation, site and equipment qualification in collaboration with relevant stakeholders. · Operate as the subject matter expert (SME) on analytical methods for various internal and external projects. Independently develop, assess and/or verify and validate analytical test methods for APIs, excipients, packaging components, devices and drug products using industry standard methodologies including QbD principles for analytical methods; US FDA or EU guidance’s and requirements; United States Pharmacopoeia (USP) guidelines; International Council for Harmonization (ICH) guidelines. Techniques may include standard tools like HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS, Rheometer etc. to more specialized techniques such as LS-MS/MS, NMR, SS-NMR, Synchrotron etc.· Act as single-point technical contact for contract research organizations (CROs) and/or contract development and manufacturing organizations (CDMOs). Collaborate with project management (PM) function to lead execution of activities against approved plan.· Provide relevant subject matter expertise in collaboration with external partners in the form of participation in technical strategy discussions; consultation on technical studies; hands-on characterization and/or third-party interface (e.g., CROs, CDMOs etc.) · Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).· Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to line functions. · Independently draft and/or review standard operating procedures (SOPs).· Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders.· Draft and/or participate in drafting relevant sections of dossiers towards 505(b)(1), 505(b)(2) or 505(j) submissions. Lead studies in support of responses to United States Federal Drug Administration (FDA) information requests or deficiency letters for various dossiers.· Train staff, peers and junior staff members on new techniques. TYPICAL DAY-TO-DAY ACTIVIES · New product development· R&D activities such as pre-formulation, formulation, process development or analytical method development· Technical Troubleshooting· Technology Transfer· Process Validations· Method Validations· New Analytical Method Development· Leading activities at CROs and CMOs· Drafting dossier supportive documents· Drafting and responding to relevant requests from the US FDA or EU authorities· Working with external partners on technical activities· Technical Management· Functional Group Management EDUCATION AND EXPERIENCE · Doctorate in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry. Decorate in Biochemistry, Peptide Chemistry or Protein Chemistry is preferred.· Successful candidate must have a strong analytical and formulation background.· In-depth understanding of UV-Vis, Liquid Chromatography (LC), Gas Chromatography (GC) and

Director R&D Analytical USA

Global Company InfoClient is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened their leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Company employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees, who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Company focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.A Pharmaceutical, also known as a company in New York, is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. Job DetailsExperience 10 – 15 YearsAnnual Salary Mid 100k-High 100k USDWork Location USADomainPharmaceuticals/Biotechnology/Clinical ResearchJob DescriptionThe Therapeutics business offers an opportunity to transform a generics company into an innovation-driven specialty business. This role is a unique opportunity to build a business with the backing of an 80-year-old legacy of sophisticated dosage forms expertise, CMC expertise, large scale manufacturing, and drug delivery. Company has a proven performance track record in 100 countries with over 1000+ products across various therapeutic categories. Company is known for creating businesses that are sustainable with a high focus on continuous innovation in R&D (with 20+ world firsts so far). Therapeutics will focus on Anti-infectives, Pain, Neurology and Respiratory therapies and building out a Branded business. Its Neurology pipeline has two early-stage assets in Spasticity, while in Respiratory, it has a Phase 2 ongoing asset for Aspergillosis in Asthma patients. It also has a Phase 3 completed “opioid-sparing” program for mild to moderate pain in hospital patients. It recently acquired an approved new generation intravenous aminoglycoside for cUTI.JOB DESCRIPTION The Director, R&D, Synthetic Organic Small Molecule Analytical Sciences position will lead all analytical sciences research and development (R&D) activities at Therapeutics. In this role the Director may lead a small team comprised of internal resources and/or contractors. The focus is on all topics analytical chemistry as applied to synthetic organic small molecule active pharmaceutical ingredient (API), formulation, process development and technology transfer. This position will report into the Senior Vice President and Head of R&D, North America. This position is based out of Warren, NJ or Long Island, NY. The job duties for this position include but are not limited to the following: · – Lead all Analytical Sciences, R&D activities as related to development and registration of synthetic organic small molecule products via 505(b)(1) and 505(b)(2) new drug application (NDA) pathways.· – Manage a team of scientists (internal and/or contractors) on all topics Analytical Sciences as applied to API, per-formulation, formulation, manufacturing process development, technology transfer, and established product support.· – – Lead technical deliverables as related to API, excipients, intermediates and finished products.· – Spearhead and/or contribute towards internal pipeline projects and collaborations with development partners (strategic development partners, CROs, CDMOs etc.).· – Operate as the subject matter expert (SME) on analytical sciences including process analytical technologies (PAT). Products may range from internal product development projects, products that are commercialized, products that are in-licensed from external entity or products that are co-developed with a development partner. – Lead and/or contribute towards API, excipient, packaging characterization; excipient compatibility and forced degradation studies. Recommend stage appropriate acceptance criteria for vendor and regulatory specifications. Utilize relevant theoretical modeling and statistical tools, as required.· – Generate, review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction. Develop and implement strategies to control related substances, where applicable.· -Work with relevant cross-functional stakeholders (e.g., Commercial Operations, Quality Control, Quality Assurance, Supply Chain Management, Procurement etc.) on analytical method transfers from R&D to commercial functions.· -Contribute towards process development, process verification/qualification, process pre-validation, process validation, site and equipment qualification in collaboration with relevant stakeholders. · -Operate as the subject matter expert (SME) on analytical methods for various internal and external projects. Independently develop, assess and/or verify and validate analytical test methods for APIs, excipients, packaging components, devices and drug products using industry standard methodologies including QbD principles for analytical methods; US FDA or EU guidance’s and requirements; United States Pharmacopoeia (USP) guidelines; International Council for Harmonization (ICH) guidelines. Techniques may include standard tools like HPLC, UPLC, UV, GC, LC-MS, Viscometer, Karl-Fisher, IR, Particle size analyses, XRPD, DVS, Rheometer etc. to more specialized techniques such as LC-MS/MS, NMR, SS-NMR etc.· — Act as SME on extractable and leachable strategies and methodology.· – Responsible to be single-point technical contact for contract research organizations (CROs) and/or contract development and manufacturing organizations (CDMOs). Collaborate with project management (PM) function to lead execution of activities against approved plan.· – Provide relevant subject matter expertise in collaboration with external partners in the form of participation in technical strategy discussions; consultation on technical studies; hands-on characterization and/or third-party interface (e.g., CROs, CDMOs etc.) · – Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).· -Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to line functions. · -Independently draft and/or review standard operating procedures (SOPs).· – Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders.· -Draft and/or participate in drafting relevant sections of NDA dossiers towards 505(b)(1) and 505(b)(2) submissions. Lead studies in support of responses to United States Federal Drug Administration (FDA) information requests or deficiency letters for various dossiers.· -Train staff, peers and junior staff members on new techniques. TYPICAL DAY-TO-DAY ACTIVES · New product development· R&D activities such analytical method development and validation· New Analytical Method Development· Method Validations· Technical Troubleshooting· Technology Transfer· Leading activities at CROs and CMOs· Drafting new drug application (NDA) dossier supportive documents· Drafting and responding to r

Regional Sales Manager (Procurement Software) – Canada

Zycus is hiring for Senior Account Executives and Regional Software Sales Manager.ZycusHeadquartered in Princeton, U.S. in 1998, Zycus has grown every day to be established as an organization which now is a leading global provider of complete Source-to-Pay suite of procurement performance solutions.We develop cloud-based (SaaS) Source-to-Pay solutions for large global enterprises, and have successfully deployed about 200 solutions to over 1000 Global clients. Our spirit of innovation and our passion to help procurement create greater business impact are reflected among procurement solution deployments that we have undertaken over the years. We are proud to have as our clients, some of the best-of- breed companies across verticals like Manufacturing, Automotives, Banking and Finance, Oil and Gas, Food Processing, Electronics, Telecommunications, Chemicals, Health and Pharma, Education and more.With a team of 1200+employees, we are present in India with 3 development centers at Bengaluru, Mumbai & Pune and offices in the U.S., U.K., Amsterdam, Australia, Dubai and Singapore.Know more about the LEADER of: Gartner’s 2018 Magic Quadrant for Strategic Sourcing Application Suites,for Strategic Sourcing Application Suites, and Gartner’s 2019 Magic Quadrant for Procure-to-Pay Suites.for Procure-to-Pay Suites.Preferred experience in ERP, SaaS, P2P_ Procure to Pay, Source to Pay, financial software product sales.Regional Software Sales Manager is an individual contributor role, reporting to the Vice President Sales.Candidates who are experienced in Software Sales, and are enthusiastic about technology, sales and new explorations, and are open to drive the role as per the parameters below, are invited to apply:1. Identifying and closing sales opportunities with fortune 1000 companies in the Canada region.2. Implement aggressively approaching strategies to identify, qualify and close accounts across domain.3. Should be able to meet the first year Sales quota (achieved through 5-6 New Logos).4. Forecast accurately the sales closures based upon realistic opportunity assessments.5. Coordinated team approach to work with an Inside sales team to maximize penetration into territory.RequirementsThe role requires a self-driven individual who has a successful Enterprise Sales experience in respective quota region with, BS Degree and 8+ years experience in quota attainment required (please mention the same on your resume while applying) Excellent engagement and solution selling skills, probing skills, negotiating skills & networking skills Open to Travel to anywhere in Canada as well as North America region. Open to work from home / remote office / regional office A Canadian Citizenship or Permanent Resident Benefits Zycus believes in an open culture learning environment, where everyone gets a chance to share their ideas and deliver par excellence. Along with a competitive compensation structure and benefits, the Role enables you to explore large open territories for your role development and be a part of a dynamic Sales team. Competitive salary and incentive bonuses, 401(k) Plan.

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