Job Title: Director Product Development
Location: Atlanta Metro Area, Georgia
Industry: Pharmaceutical & Biotech
- Direct and lead the effective development and/or transfer of products, methods, processes, and technology.
- Support senior management and Business Development in due diligence, selection and commercialization of new products and technologies from external partners
- Interact directly with internal and external clients in relation to tech transfers, new product introductions, technology enhancements and process improvements where appropriate.
- Provide scientific leadership for the site in the areas of manufacturing technology, processes, and regulatory requirements.
- Operational management of the Product Development group in the areas of
- Objective setting and Performance Reviews
- Responsible for hiring all members of the Product Development team and ensuring they are adequately trained to perform all necessary tasks of their roles
- Responsible for documentation generation, review, and approval as required, particularly, but not exclusively in the areas of Product Development, CMC, Tech Transfer and Validation.
- cGMP and Training
- Budget preparation and monitoring
- Project Management
- Working knowledge of GLP/cGMP regulations and safety procedures.
- Good working knowledge of MS Office (Word, Excel, PowerPoint, Access, and Outlook), Sigmaplot and JMP or equivalent and experience with the internet.
- Strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development.
- Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
- Ability to respond to common inquires or complaints from regulatory agencies, or members of the business community.
- Ability to write speeches and articles for publication that conform to prescribed style and format.
- Ability to present information effectively to top management, public groups, and client companies.
- Ability to apply mathematical operations to such tasks as determination of test reliability and validity, statistical analysis including but not limited to frequency distribution, analysis of variance, correlation techniques, sampling theory, and factor analysis.
- Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
- Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases.
- Ability to deal with a variety of abstract and concrete variables.
- Education: MS Degree in Pharmaceutical Sciences, Chemical Engineering or related discipline is highly preferred.
- Experience: Ten (10) years of relevant work experience in pharmaceutical product development, and at least five (5) + years in oral controlled release product development; Five (5+) years prior supervisory management experience. Prior management role within a contract development and manufacturing organization (CDMO) is highly preferred.
We are in the people business; treating people right is our ONLY priority. Theoris Services consultants are full-time employees with full benefits, including:
- Robust Health Insurance
- 401(k) plan
- PTO accrual
- Paid holidays
- Excellent cash-based referral program
Our goal is to Fuel Your Career! As a Theoris team member, you join a culture based on people-centered values and an environment that fosters both personal and professional growth. We build long-term relationships with our clients and our consultants. With over 30 years of building strong relationships in the industry, we’re uniquely positioned to make the right connections. This knowledge is used to find the right job placement. Our recruiting teams are experts dedicated to the information technology and engineering staffing space and are highly respected by our client base.