Senior Director of Manufacturing Science and Technology
3 days ago
Tanvex BioPharma Inc is seeking a highly experienced and skilled Associate Director to lead and enable the Manufacturing Science and Technology (MSAT) team as a strategic champion, manager, and Subject Matter Expert (SME) for mammalian and microbial drug substance manufacturing of biologics for clinical and commercial use in our contract development and manufacturing (CDMO) and in-house programs.
Key Responsibilities- Apply advanced engineering principles to the transfer, monitoring, validation, and troubleshooting activities of drug substance manufacturing processes.
- Partner with cross-functional teams at decision level, including Process Development, Quality, Supply Chain Management, External Manufacturing (Drug Product), Engineering, and all clients.
- Drive implementation of new technologies to improve manufacturing efficiency and ease of operations.
- Plan and implement long-range technology programs, proposing, designing, and implementing advanced scientific experiments that contribute to overall program objectives and extend the boundary of knowledge in their field.
- Oversight of all MSAT client interactions.
- Manage and develop the MSAT team through individual goal setting, performance reviews, motivating employees, providing coaching and feedback for individual career growth and development, recognizing and appreciating employee contributions, mitigating conflict and communication problems, planning and facilitating team activities, recruiting and hiring personnel, providing training, and emphasizing best practices.
- Bachelor's or advanced degree in chemical/biochemical engineering, chemistry/biochemistry, biological sciences, or related disciplines.
- BS with 15 years of relevant experience, or MS with 10 years of relevant experience, or PhD with 5 years of relevant experience in biopharmaceutical research and manufacturing settings.
- 5 years of management experience required.
- Advanced experience with biopharmaceutical manufacturing process and equipment.
- Proven track record of leading MSAT functions and implementing MSAT strategies.
- Extensive knowledge of cGMP regulations/guidance and quality systems.
- Must have an advanced understanding of statistical methods and their application in technology transfer and product lifecycle.
- Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
- Proficiency with MS Word, Excel, and PowerPoint.
- Familiarity with statistical software, such as JMP, is desirable.
- Excellent interpersonal, verbal, and written communication skills as well as digital literacy.
- Ability to function efficiently and independently in a changing environment.
- Proactive and willing to accept temporary responsibilities outside of initial job description.
- Required to spend up to 80% of their time working in a standard office environment.
- Regularly required to talk and hear; to exchange ideas accurately, loudly or quickly through oral communication.
- Required to perform repetitive tasks such as typing, use of mouse, and pipetting.
- Consistently required to perform sitting, standing for sustained periods of time, reaching, twisting, handling, fingering, and feeling objects such as tools and controls.
- Occasionally required to climb stairs, ramps, and step ladders.
- Occasionally involves stooping, balancing, kneeling, crouching, and feeling.
- Required to work within a biosafety level 1 laboratory environment.
- Required to operate standard lab equipment such as HPLC machines, glass wash, autoclave, etc.
- Required to wear safety glasses, lab coats, and disposable gloves as part of their daily job duties.
- Routinely uses large-scale manufacturing equipment including skids with dials, buttons, and chambers and computer workstations.
- Additional personal protective equipment may be required for additional hazards.
- Frequently required to work with hazardous chemicals which may pose a health and physical hazard.
- Required to transport biological samples, waste material, chemicals, supplies, and equipment.
- Required to work with sharps contaminated with chemicals which may pose a percutaneous hazard.
- On occasion, the employee may work on weekends or nights, or on-call as needed.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions for this position.
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