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The Staffing Resource Group, Inc
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http://www.srg-us.com
http://www.srg-us.com
Director of Process Chemistry
Richmond, VA
Posted: 02/03/2021
2021-02-03
2021-03-30
Job Number: JN -022021-12483
Job Description
Director of Process Chemistry Manufacturing, Science & Technology (MS&T)
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
Overview:
The purpose of this role is to manage partner Contract Development Manufacturing Organizations (CDMOs) to ensure excellent Active Pharmaceutical Ingredients (API) manufacturing process development, technical transfer, validation and commercial manufacture of companies target APIs, and to drive continuous improvement, when appropriate. The candidate will be a partner-facing leader who personifies companies shared values and culture, both internally and externally. This role s scope spans from process design and development through manufacturing and regulatory submission. The candidate will work with the highest standards of integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues.
Responsibilities:
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
- Title: Director of Process Chemistry Manufacturing, Science & Technology (MS&T)
- Location: Richmond, VA (On-site, not remote)
- Industry: Pharmaceutical
- Hours: M-F, 8am-5pm
- Employment Type: Direct hire
- Salary: Competitive compensation package, bonus potential and excellent benefits package
Overview:
The purpose of this role is to manage partner Contract Development Manufacturing Organizations (CDMOs) to ensure excellent Active Pharmaceutical Ingredients (API) manufacturing process development, technical transfer, validation and commercial manufacture of companies target APIs, and to drive continuous improvement, when appropriate. The candidate will be a partner-facing leader who personifies companies shared values and culture, both internally and externally. This role s scope spans from process design and development through manufacturing and regulatory submission. The candidate will work with the highest standards of integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues.
Responsibilities:
- Manage R&D development partners to ensure a scalable, cost-competitive manufacturing process is developed on time, on budget and ready for technology transfer to manufacturing partners
- Manage manufacturing partners to ensure that manufacturing processes are successfully validated and product manufactured on time and on budget
- Review, author and approve manufacturing process documentation such as process development protocols and reports, batch records, validation protocols and reports, specifications, etc.
- Contribute to the timely and accurate preparation of regulatory submissions
- Supervise the ongoing continuous improvements in manufacturing processes resulting in improving product quality, robustness, and cost
- Manage multiple projects/workstreams and make sound and timely decisions based on business priorities
- Assist as a process chemistry SME for CRO/CDMO/CMO audits
- Collaborate with Project Management, Analytical Chemistry, Quality Assurance, Regulatory Affairs, and Engineering to ensure strong working relationships with all partners and company employees
- Minimum of 10 years working in related roles in the pharmaceutical industry demonstrating increasing responsibility
- Strong track record of success including process development, technology transfer, and continuous improvement
- Strong interpersonal and communication skills
- PhD (or equivalent based upon work experience) in Organic Chemistry, Pharmaceutical Sciences or a related scientific field
- Significant process chemistry and API manufacturing experience on multi-kilogram scale
- Experience with generic API development, technology transfer and manufacture
- Knowledge of ICH and cGMP requirements
- Experience managing third-party vendors (CROs/CMOs/CDMOs)
- Experience with technical and operational risk assessments (e.g., process robustness, mutagenic impurities, nitrosamines, etc.)
- Experience with design of experiments (DOE) and related multivariate experimentation approaches
- Experience with the development and implementation of continuous flow manufacturing processes is a plus
- Experience authoring or contributing to regulatory submissions (NDAs/ANDAs/DMFs)
