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Recruitment Consultant - Life Science and Engineering at Berkley Group
Tech Transfer Lead (Intermediate)
This role requires providing process development support primarily for new product introductions (NPI) and lifecycle management (LCM) changes at ADL. The candidate will establish themselves as a product lead, primarily leading process performance qualification (PPQ). Additionally, the candidate will provide technical support to biologics drug product manufacturing at ADL within the global Process Development organization. Responsibilities include:
1. Leading new product introductions to ADL PM2 and PM3 from a Process Development perspective and serving as the SME after transfer completion.
2. Managing the product transfer project from initiation to regulatory approval.
3. Troubleshooting issues related to drug substance freezing/thawing, formulation, filling, lyophilisation, inspection, and transportation.
4. Providing process development expertise in sterile processing, process characterization, tech transfer, and validation.
5. Supporting manufacturing operations with technical evaluations of Change Control/NC/CAPA and tech transfer.
The position reports to the Process Development Senior Engineer and may require moderate international travel.
Responsibilities:
* Develop validation plans and process performance qualifications for vial and syringe filling.
* Ensure activities comply with policies, procedures, safety, and training requirements.
* Meet quality standards and regulations (FDA, EU, and international) related to CMC business processes.
* Participate in cross-functional process validation teams to ensure adherence to policies and project milestones.
* Pre-approve and post-approve process validation protocols and assessments.
* Communicate effectively across functions and sites, collaborating with all relevant groups.
* Act as the primary contact for drug product transfer projects at the ADL site.
* Assist in maintaining and developing validation programs for compliance.
* Report on shipping and filter validation activities.
* Support deviation resolution and root cause analysis.
* Contribute to product quality assessments and process flow documentation.
Basic Qualifications:
* Bachelor's degree in science, engineering, or a relevant discipline with 5 years of experience, or Master's degree with 3 years, or Associate's degree with 10 years of experience.
* Knowledge of cGMPs and global regulatory requirements.
* Strong problem-solving skills and excellent communication skills.
Preferred Qualifications:
* Doctorate or Master's in Science or Engineering.
* Over 5 years of experience supporting commercial protein drug product processing, including sterile processing, process characterization, tech transfer, or validation.
* Expertise in protein freeze-thawing, filtration, mixing, filling, and lyophilisation processes, including knowledge of protein biochemistry.
* Strong project management skills for handling multiple projects.
* Deep understanding of quality systems, drug product manufacturing, and validation.
* Leadership experience in cross-functional project teams with excellent communication skills.
Additional Details:
* Seniority level: Entry level
* Employment type: Contract
* Job function: Other
* Industry: Pharmaceutical Manufacturing
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