The Opportunity:We're seeking a highly experienced and strategic MSAT Process Engineering Lead to manage a group of engineers through process design, qualification, startup and registration at our state-of-the-art manufacturing site. This position will oversee the process aspects of Compounding/Formulation/Filling/Inspection of sterile drug product, which will then be assembled and packaged into autoinjectors and multi-dose pens. This is a key role in site management to develop the process engineering staff to be interface to global technology implementation and development interfaces, as well as play a key role for developing the regulatory filing and approval strategy alongside the global and site functions.
What you'll do:- You will provide clear objectives, coaching, and continued development opportunities to direct reports
- You will support the project leadership and co-lead project teams to ensure the processes implemented meet cGMP/regulatory requirements
- You will provide technical expertise and input on the design and implementation of production equipment
- You will ensure implementation of quality systems and SOPs on site for tech transfer, filter validation, process validation, mixing characterization, leachable/extractables, aseptic simulations, and cleaning validations in conjunction with the site Validation Lead
- You will ensure processes transferred meet characterization expectations for critical and key process parameters
- You will ensure proper implementation of process and microbial control strategies for all processes implemented at site
- You will design and execute studies and comparability protocols to support the required operations
- You will perform cross-functional risk assessments required for process controls.
- You will ensure PPQ pre-requisites are met in time for site start up and launch
- You will participate in creation, review, and approval of regulator dossier section for site licensure
- You will provide input to strategic and streamlined approaches for all validation activities
- You will ensure appropriate specifications are in developed for direct raw materials and process IPCs and outputs and release.
- You will foster a positive safety culture into the department and department operations ensure all SHE guideline are followed
- You will contribute to the continued improvements to OEE and process COGS
- You will ensure business continuity risk assessments are conducted on process raw materials, process quality characteristics, and identification of secondary suppliers
- You will provide knowledge and training on complex process and equipment technologies to all required partners. You will provide training materials and training for people joining the organization. You will act as a coach for colleagues with less experience and helps them develop skills/expertise
Who you are:- You hold a Bachelor's, Master's, or Ph.D. degree in bio/chemical engineering or similar and have 12+ years experience in technology of pharmaceutical industry
- Minimum of 5 years of people management experience
- You are a recognized expert (technical and/or operational) in drug product manufacturing relevant unit operations (Compounding, Filling, Inspection) Relevant experience in data science/engineering, analytics, etc. to drive the concept of smart factory is desirable
- Prior experience with technology transfers, process validation, authoring regulatory submissions, and Health Authority inspections is required
- You have up-to-date knowledge of cGMP's, Health Authority regulations, and Quality Systems.
Preferred:
- You are able to organize and solve complex, unique or unprecedented problems through the regular use of ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results.
- You have advanced project management skills: demonstrated ability of technology implementation and start-up
- You have relevant contact with collaborators, regulatory agencies, and vendors inside and outside the company including coordination across organizational lines, including advising and influencing senior management on advanced technical matters. Utilizes an established network for technical issues within the company and the industry.
Work Environment/Safety Considerations:
- This role requires full onsite work at the project office before transitioning to the site offices.
- Ability to work in an international/global environment. Domestic and international travel required. Travel up to 20% after full relocation.
- May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves, and steel toe boots.
The expected salary range for this position based on the primary location of Holly Springs, North Carolina is $151,000 - $281,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Relocation benefits are provided.
Link to Benefits
