At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions. We are committed to fostering an environment that is professional and forth right. These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success. We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance. At Pharmatech talent matters, and we tackle each project with a “no fear” attitude. We stand together as a team, and we’ve got your back. Pharmatech’s commitment to integrity is unwavering.
Reports To: VP of Product and Process Development
- Responsible for the overall direction, coordination, implementation, execution, control and completion of specific projects ensuring consistency with company strategy, commitments and goals.
- Accountable for growing Pharmatech’s Product and Process Development sphere through sales development, outstanding project management and exceptional client relationship management.
- As a member of the senior leadership team, participate in strategic and operational decision-making processes necessary for the successful attainment of the organization’s initiatives.
- Assemble world-class consulting teams by actively supporting recruitment efforts, including negotiating compensation, and providing growth and mentorship opportunities.
- Produce communications tools for reporting project progress and project completion reports.
- Direct the design and scale-up of pharmaceutical, biotech and Med Device manufacturing processes.
- Perform data collection and analysis to support new and ongoing process development and scale up activities.
- Select appropriate instruments and equipment from the laboratory through pilot plant and manufacturing scale-up.
- Provide broad based consulting services to regulated life sciences clients; such services will include project management as well as execution of project deliverables.
- Serve as a QbD subject matter expert with respect to formulation development, process development, process transfer and scale up, and process validation. This includes solid and liquid dosage forms, liquid and cream products, and biologics including packaging, cGMP systems and requirements.
- Design processes for validation, product/process transfers and continued process verification; including data analysis, gap analysis, identification of critical technical and compliance requirements, technical and compliance documentation review, and process metrics.
- Direct the design and scale-up of pharmaceutical and biotech manufacturing processes, select appropriate instruments and equipment from the laboratory through pilot plant and manufacturing scale-up. Identify opportunities to reduce process variability which includes, but not limited to, conceptualizing and directing equipment solutions and refining /updating procedures and operational checklists and training guides
- Identify and hire professionals with the capabilities of executing and supporting the strategic vision and tactical plan for the Products and Process Development
- Bachelor or Master’s Degree with a scientific or engineering related major is required
- Minimum of 10- 15 years’ experience required. Experience within a manufacturing environment for FDA regulated products. At least 5 years of formal and direct client management in a consulting role
- Experienced in performing a wide range of formulation, process development and validation of multiple pharmaceutical/biological dosage forms
- Strong CMC understanding and process design experience and understanding
- Solid experience with writing and evaluating technical content for regulatory submissions for pharmaceutical, biologics, cellular therapy and/or combination products, including IND’s, NDA’s and BLA’s
- Essential knowledge of QRM, QbD and QMS frameworks, along with strong practical knowledge of ICH, FDA and EMA
- Excellent understanding of process design, process characterization and scale up consideration as well as optimization principles
- Must be current and proficient in; newly introduced global concepts, practices, and procedures within the regulated life sciences industry
- Outstanding personnel management skills and demonstrated leadership capabilities with a proven ability to work cross-functionally within client organizations
- Has built and managed professional engineers as part of an organization
- Outstanding communication (written and verbal) and interpersonal skills with the ability to work in a team environment is a must
- Capable to travel and work remotely at client sites throughout the United States and internationally
- Early and late stage drug development experience a plus
- Custom automation experience a plus