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Process development engineer • cambridge ma
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Position : Director, Process Development .An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_30
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Job Title : Process Development Engineer.We are seeking a Process Development Engineer to support the transfer and optimization of purification processes for biologics drug substance manufacturing.I...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
Our client is currently seeking a.The individual will be responsible for the design, programming, monitoring and maintenance of production and facilities process automation systems.Job duties inclu...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
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Job DescriptionJob DescriptionDescription : .Elektrofi is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life-c...serp_jobs.internal_linking.show_moreserp_jobs.last_updated.last_updated_variable_days
We are proud to be partnering with a leading biopharmaceutical organization on an exciting search for an Associate Director of Downstream Process Development.
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Dir, Process Development
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Dir, Process Development
AlkermesWaltham, MA, United Statesjob_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionPhD or MS in Science or Engineering 15+ years technical and leadership experience in pharmaceutical development. This should include experience in Process Development, scaleup and GMP manufacturing with an established history of successfully developing and commercializing products and processes. Expertise and demonstrated experience in small molecule process development, scale up, control strategy development and technical transfer. Expertise in design of experiments, data analysis and data interpretation for process development studies. Experience managing contract drug development activities. Technical problem-solving ability utilizing current research and technologies. Broad understanding of the drug development process and the role and impact of process development within this process Expert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development. Strategic thinking and planning ability. Demonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills. Demonstrated ability to work successfully in a fast-paced team / matrix environment as well as independently manage priorities and maintain timelines for multiple activities.
Position : Director, Process Development
Position Summary :
An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development activities at the Waltham site, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients.
This position is responsible for leading and empowering the Process Development Team in taking Alkermes’ drug product candidates from formulation development through process development, scale-up, optimization, process characterization, clinical production, and technical transfer to the commercial manufacturing site.
The successful candidate will thrive in a highly collaborative matrix team environment to drive critical decision-making and ensure the successful development of new drugs.
Responsibilities and Requirements :
- Lead process development strategy for Alkermes products and ensure processes are suitable for the phase of development and ultimately for commercial manufacturing. This includes process design and development, scale-up and optimization, characterization and control strategy development and technical transfer to internal manufacturing site or CMO / CDMOs
- Recruit, manage, train, motivate, develop, and mentor Process Development staff.
- Collaborate closely with colleagues across Pharmaceutical Development and Manufacturing organizations to best leverage internal and / or external capabilities to assist in process development effort.
- Ensure process development approaches are suitable for progressive stages of small molecule pharmaceutical development as outlined in ICH and FDA guidance.
- Operation of the Process Development laboratories and GMP clinical manufacturing suites which are currently under development in Waltham, MA.
- Provide subject matter expertise in process development methodologies at Alkermes requiring internal execution and technical oversight / supervision.
- Present technical data to cross functional teams and senior management as a process development expert, and effectively communicate critical process issues and solutions.
- Guide and drive process development, design of experiments, product characterization and control strategy development.
- Develop, review, and approve process development source documents, and author and review drug product process development sections for regulatory submissions.
- Ensure the team stays up to date with current technologies and manufacturing trends focusing on continuous improvement and operational excellence.
- Managing the team budget and supporting the planning of capital requirements for the future
- Support the Regulatory group in responding to agency questions.
- Support process validation and commercial launch
- Provide technical support to internal manufacturing sites and CMOs.
Qualifications and Requirements :
LI-RS1
Onsite