Job: Senior CMC Scientist, Camargo Pharmaceutical Services, Durham, NC
Camargo Pharmaceutical Services is excited to announce that we are now seeking a Senior CMC Scientist. The Senior CMC Scientist utilizes in-house and external resources to systematically design and execute product development plans that align with business strategies on project assignments. The Senior CMC Scientist collaborates with the Development and Regulatory Sciences team to guide the research, writing, and editing of scientific, medical, and regulatory documentation needed for communications with Sponsors, Partners, and Regulators, and participates in preparing other documents necessary for project assignments. The Senior CMC Scientist also assesses the pharmaceutical and regulatory viability of product development opportunities in coordination with other technical functions within Development and Regulatory Sciences.
Who You Are:
* You love working with people. You are collaborative, upbeat, and optimistic. Operational excellence and providing outstanding internal and external customer service are second nature to you.
* You are a problem solver with a can-do, roll-up-your-sleeves spirit.
* You are exceptionally organized, detail-oriented and self-directed.
* You are a proactive and clear communicator.
What You’ll Do:
* You will manage relevant aspects of product development proposals such as strategy and objective of project, testing models, claims support, costs of project, timing, regulatory implications, and human resource requirements.
* You’ll manage pre-formulation and formulation studies of drug products using quality risk management techniques and collaborate with regulatory and operations departments to assure that specifications are in place for vendor sourced product components.
* You’ll provide CMC expertise on project teams such as feasibility/gap analysis, Types A, B or C FDA meetings, interactions with other regulatory authorities, regulatory submissions such as INDs, NDAs , etc.
* You’ll function as Team Lead on complex projects, utilizing standard project management processes, tools, and strategies to meet the time, cost, and quality needs of clients.
* You will drive high levels of client satisfaction through strategy development, project planning, project execution, and consistent communication.
* Through your leadership, you’ll grow future leaders through mentorship and guidance in your area of expertise.
* Ph.D. in Pharmacy, Chemistry/Biochemistry, Engineering or related field plus 3-6 years relevant pharmaceutical experience, or MS in the same fields plus 8 to 10 years’ experience.
* Experience in drug or biologics development, including formulation development, drug substance and product testing, process development, in GxP environments
* Late stage technical ownership of analytical/formulation/process development, process transfers/scale-up, process/equipment validation/qualification, and drug substance/drug product site auditing for a variety of dosage forms and drug chemistries.
* Demonstrated experience preparing documentation suitable for FDA submissions and meetings.
* Detailed knowledge of cGMP and Regulatory requirements for product development.
* Ability to work collaboratively in a team environment, including with global companies and sponsors.
* Ability to participate in drug manufacturing audits or process monitoring while wearing personal protection equipment (PPE) as needed.
* Travel 10-15% of the time, including inter-office travel.