Job Description

Job Description

Mission and Culture

We advance health through innovation by developing and manufacturing therapies that improve patients' quality of life. Every employee plays a vital role in our mission to advance human health through innovative client partnerships. Whether you’re involved in development, manufacturing, testing, or contributing your expertise in other areas, your work will have a meaningful, positive impact on countless lives.

Do you:

• Love finding new and better ways to do things?
• Want to help develop medicines that improve patients' lives?
• Have a passion for learning and growth?
• Nerd out on science and technology?
• Value collaboration and teamwork?
• Embrace audacity and entrepreneurial thinking?
• Prioritize safety and lead by example?
• Care deeply about doing the right thing?

We foster a diverse, inclusive, challenging, and supportive culture. We are committed to continuous improvement, both as individuals and as an organization, and we encourage personal and professional development at every level. Join us to make a real difference in patients’ lives through your work.

Your New Role

In this role, you will support product development strategies on client projects and provide strategic input into departmental activities to ensure flexibility and timeliness in achieving client timelines. You will be responsible for the formulation development and process optimization of challenging pharmaceutical products such as controlled-release oral solid dosage forms (tablets, multiparticulates, etc.).

You will also:

• Independently lead development activities for client-based projects, ranging from preclinical studies to NDA approval. This includes creating phase-appropriate strategies for customer-defined product development projects.
• Execute prototype, scale-up and process transfer activities including manufacture, data evaluation, troubleshooting product/process issues, and risk assessments.
• Write, review, and approve cGMP documentation including batch records, protocols, SOPs, pharmaceutical development reports, investigation plans, and outcomes for development problems.
• Maintain expert knowledge of equipment, instrumentation, and procedures related to product development.
• Attend cGMP training sessions and comply with site-wide and departmental procedures, including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.
• Serve as lead for product development activities within the pharmaceutical development group and on cross-departmental project teams, working closely with cross-functional groups to achieve project deliverables.
• Partner with department leadership and other research experts to develop new concepts. Assist in developing project plans, business analysis, department budget planning, and feasibility assessments.
• Identify and develop specific training content to support ongoing development efforts. Provide leadership and mentorship to junior team members. Support in developing group priorities, goals, and objectives, and ensure staff are adequately trained to perform job functions.

Education and Experience

• Bachelor’s degree in Pharmaceutics, Physical Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering, Pharmacology with 12+ years of experience in formulation and process development of oral solid dosage forms (tablets, capsules, multiparticulates), OR a Master’s degree with 8+ years of relevant experience.
• Minimum of 1 year of experience leading and managing teams.

Knowledge, Skills, and Abilities

• In-depth knowledge of theory and techniques used in pharmaceutics and physical organic chemistry.
• Strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development.
• Proven experience with statistical design of experiments.
• Strong written and oral communication skills.
• Proficient in MS Office (Word, Excel, PowerPoint, Access, and Outlook), Minitab, JMP or equivalent.
• Ability to prepare presentations, speeches, and articles for publication that conform to prescribed style and format.
• Ability to present technical presentations to management, research teams, and clients/potential clients to ensure understanding and respond to complex questions.
• Ability to apply logical or scientific thinking principles to a wide range of intellectual and practical problems.
• Strong working knowledge of regulatory requirements, including FDA, EMEA, ICH, and regulations in regard to IID, GRAS, residual solvents, bioequivalence studies, etc. for oral formulations.

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