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Alkermes
Waltham, MA, United States
Job Description An exciting opportunity for an experienced leader to join as a key member of the Pharmaceutical Development team with responsibility for process development activities within the business, ensuring delivery of robust processes that enable the consistent manufacture of high quality and life changing therapeutics for patients. This
Job Source: AlkermesTome Biosciences
Watertown, MA, United States
At Tome, we are developing the next generation of programmable genomic integration technology. Our technologies allow us to insert any genetic sequence of any size at any location into any genome. We are building an exceptional team and a work environment that is diverse, innovative, rewarding, and fun. We have an opportunity to re-write the patien
Job Source: Tome BiosciencesTome Biosciences
Watertown, MA, United States
At Tome, we are developing the next generation of programmable genomic integration technology. Our technologies allow us to insert any genetic sequence of any size at any location into any genome. We are building an exceptional team and a work environment that is diverse, innovative, rewarding, and fun. We have an opportunity to re-write the patien
Job Source: Tome BiosciencesApex Systems
Cambridge, MA, United States
Associate Director, Downstream Process Development (Proteins) 2033669 Location : Cambridge, MA (Onsite) Science: Protein Therapeutics Job Overview: This hands on leader will operate in a cross functional leadership role to facilitate the development and technology transfer efforts of protein therapeutics to external CDMO’s. Primary Job Responsibi
Job Source: Apex SystemsGarudatx
Burlington, MA, United States
Garuda Therapeutics, a biotechnology company focused on developing off-the-shelf human hematopoietic stem cell-based cellular therapies, is seeking a highly motivated associate / senior associate to join its growing team. The full-time role will be a key member of the process development team, focusing on scaling up pluripotent stem cell expansion
Job Source: GarudatxHP Hood LLC
Wilmington, MA, United States
Description Are you a self-driven person looking to advance your career as a high-impact player on a team? If so, we have an exciting challenge for you and your future! At HP Hood LLC, we celebrate our differences. Our diversity of people, backgrounds, experiences, thoughts and perspectives are fostered to create an inclusive work environment. We
Job Source: HP Hood LLCGaruda Therapeutics, Inc.
Watertown
Job Description Job Description Garuda Therapeutics, a biotechnology company focused on developing off-the-shelf human hematopoietic stem cell-based cellular therapies, is seeking a highly motivated Scientist to join its growing team. The full-time role will be a key member of the process development team, focusing on scaling up pluripotent stem
Job Source: Garuda Therapeutics, Inc.Alkermes
Waltham, MA, United States
Job Description This position designs and executes experimental studies to develop well understood, robust oral solid dosage manufacturing processes. Key duties are process design, equipment set-up, troubleshooting equipment, running experiments, collecting, and evaluating data to identify and implement process/equipment improvements reducing wast
Job Source: AlkermesCambridge, MA, United States
Who are we?
We are a next-generation gene editing company focused on discovering and developing potentially curative genomic medicines, with the most extensive toolbox of proprietary genomic editors in the industry. We have the unique ability to work backward from disease pathology and choose the optimal editors or combination of editors for the disease in question. Find out more at arbor.bio.
Who are you?
Passionate, determined, and accountable. Curious, resourceful, innovative, forward thinking, and resilient. Authentic, humble, open-minded and puts team above self. At Arbor, our people embrace these qualities, so if this sounds like you then please read on!
About The Role:
As the Director, Process Development, you will report to the VP of CMC and provide strategic leadership to develop, establish, and drive the execution of the organization. You will develop scalable manufacturing processes to support Arbor's gene editing pipeline. You will define and execute process development and tech transfer activities to enable efficiency and differentiation in GMP manufacturing throughout the product lifecycle. You will establish and implement best practices for generation and integration of product and process knowledge across the groups accountable for analytical testing, formulation, process development, process characterization and introduction of products into fill/finish operations.
What You Can Expect:
• Owns the technical knowledge flow and cross functional integration required to secure completion of activities assigned across Product Development (Formulation), Process Development and its overall Transfer into Manufacturing.
• Leads, guide and delivers outcomes in close partnership with the managers and lead scientists in charge of knowledge and clinical materials generation.
• Oversees integration of control strategy elements including in-process and release testing for materials and products.
• Directs staff and activities associated with Formulation and Product Development activities executed at Lab scale prior to their transfer into production.
• Directs staff and activities associated with process development and associated characterization studies geared toward process transfer into production.
• Drives innovative improvements in R&D to reduce cost, lead times and improve throughput.
• Represents Process Development and Tech Ops in cross functional meetings. Sponsors integration of quality and innovative solutions culture. Leads continual improvement efforts.
What You Bring:
• Bachelor's degree in scientific discipline
• Minimum of 10 years' experience in biotech, pharma and/or life sciences
• Viral vector experience with preference toward AAV
• Experience with synthetic and IVT RNA products is highly desired
• Familiarity with LNP formulations are a plus
• Experience with Six Sigma, Lean manufacturing, Value Stream mapping experience a plus
• Experience working in a startup that grew rapidly a plus
• Positive attitude and good judgment, a person people seek out for advice
• Excellent communication skills - oral, written, listening, inclusive of others' ideas
• Trustworthiness, personal integrity; able to maintain a high degree of confidentiality
• Effective time management and organizational skills
• Personal accountability, learning agility, collaboration, personal touch and stewardship
Our Values:
Our values govern the work we do at Arbor, and we're hoping that they resonate as strongly with you as they do with us!
• Purposeful Action: Start with The Why
• Bold Resilience: Adopt a Growth Mindset
• Humble Authenticity: Start in the Heart
We promote diversity and inclusion not just in our recruitment processes, but in everything we do. We're an equal opportunity employer and we will continue to ensure our recruitment process is free of bias and our workplace is inclusive, positive, and free of discrimination and respecting of all backgrounds and beliefs.
Email Alert for Director, Process Development jobs in Cambridge, MA, United States
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