Senior Process Development Manager
5 days ago
The Senior Process Development Manager will oversee technical delivery of new product introductions and life cycle management products. This role requires strong leadership skills in leading tech transfers, process validation activities, and managing teams in the pharmaceutical or biotech industry.
Key Responsibilities:- Lead a team of tech transfer engineers/scientists for NPIs and LCMs to achieve business objectives.
- Provide technical expertise for large molecule and small molecule drug product manufacturing.
- Support process performance and implement process improvement strategies.
- Lead new product introductions and lifecycle changes into the vial and syringe plants from a Process Development perspective.
- Act as a drug product manufacturing technical expert to troubleshoot issues with drug product processing technologies and equipment.
- Develop and characterize drug product processes and transfers technology to commercial drug product sites.
- Troubleshoot issues with drug product processing technologies and equipment.
- Lead and conduct risk assessments for drug product operations and propose / implement appropriate CAPA.
- Provide support to the PD forensic lab and be a link to manufacturing on key investigations as a process expert.
- A third level Bachelor's degree in Science, Engineering or a relevant Quality discipline with 5 years' experience in a similar role OR Master's degree & 3 years of directly related experience OR Associate's degree & 10 years of directly related experience.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Problem solving ability and excellent oral and written communications skills.
- PhD or Masters in Science or Engineering.
- 5 + years of experience in support of Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
- Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of protein freeze-thawing, filtration, mixing, filling, and/or lyophilization processes.
- Knowledge of protein biochemistry regarding chemical and physical stability.
- Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
- Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
- Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion.
- Excellent Communication skill is essential for this role.
Equal opportunities employer.
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