Associate Director of Manufacturing
4 weeks ago
Landmark Bio translates groundbreaking research into life-changing medicines. We provide development, manufacturing, and regulatory capabilities to help early-stage life science innovators rapidly progress advanced therapies from bench to clinic. Launched in 2021, and based in Watertown, Mass. Landmark Bio is an unprecedented venture bringing together the best of industry, academia and research hospitals to accelerate life sciences innovation. A public benefit company, our work advances emerging technologies, demonstrates therapeutic potential, and improves human health.We are seeking a highly motivated and team-oriented professional with entrepreneurial spirit to join our company This is an exciting opportunity for a well-qualified candidate to join a rapidly growing company focused on turning today's cutting-edge research into tomorrow's breakthrough therapies.You'll lead a dynamic cross-functional team in producing clinical supply products under cGMP conditions. Your responsibilities include ensuring safe, high-quality, and efficient product delivery while fostering employee development and engagement. You'll play a pivotal role in establishing and optimizing Viral Vector and Fill Finish Operations during the start-up phase. As a member of the Tech Ops Leadership Team, you'll contribute to strategic planning and cross-functional collaboration.Scope of Responsibilities•Lead a cross-functional Production Team to produce clinical supply products under cGMP conditions in a Lean Manufacturing environment.•Responsible for safe, high-quality, compliant, and efficient product delivery, as well as financial diligence.•Mentor employees to foster a culture of engagement, learning, and growth.•Establish philosophies, operability, and business processes for the GMP manufacturing area and team during the start-up phase.•Provide expertise on GMP, lean operations, operational fit and efficient production scheduling as the designated Technical Lead for facility start-up or New Product Introduction projects.•Train and develop the team to create a high-performance culture.•Maintain manufacturing area readiness for production and GMP audits.•Implement continuous improvement activities and support organizational development.•Drive performance to achieve production goals, identify and resolve gaps.•Facilitate decision making via effective communication with internal and external stakeholders, including senior management.•As typical in a growing organization, the incumbent works in a broad and deep span of control, modulating between strategic and tactical / hands-on aspects of the role until the facility is fully utilized and a full Manufacturing function is established. For example, of hands-on activities, they must be comfortable and capable writing/drafting/editing GMP docs and guiding on-floor operation, etc . Qualifications•Degree in Science/Engineering preferred.•Experience in pharmaceutical/biotechnology operations, specifically in Viral Vector and/or Fill Finish Operations is required. •Understanding of GMP.•5+ years of team leadership experience.•Hosting regulatory audits and developing audit presentations.•Lean Manufacturing projects or qualifications•Project leadership skills and ability to develop effective working relationships.•to make impactful decisions and foster a culture of innovation.•communication and interpersonal skills.•Experience in related functional areas outside of manufacturing is a plus.Landmark Bio is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.
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Watertown, United States Tome Biosciences Full timeAt 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 patient story,...
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Watertown, United States Tome Biosciences Full timeAt 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 patient story,...
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Director, Commercial Manufacturing
1 week ago
Watertown, United States Deciphera Pharmaceuticals Full timeCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.Enabled by...
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Director, Commercial Manufacturing
4 hours ago
Watertown, United States Deciphera Pharmaceuticals Full timeCompany DescriptionDeciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.Enabled by...
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Director, Commercial Manufacturing
5 days ago
Watertown, United States Deciphera Pharmaceuticals Full timeCompany Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled by...
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Associate Director, Quality Systems
2 months ago
Watertown, United States Affini-T Full timeJob DescriptionJob DescriptionAbout Affini-T Therapeutics Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant...
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Associate Director, Quality Systems
3 weeks ago
Watertown, United States Affini-T Full timeAbout Affini-T Therapeutics Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a "best-in-class" TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases. Through the application of...
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Associate Director, Quality Systems
12 hours ago
Watertown, United States Affini-T Full timeJob DescriptionJob DescriptionAbout Affini-T Therapeutics Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant...
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GMP Manufacturing Technician
2 weeks ago
Watertown, United States Anansys Staffing LLC Full timeJob DescriptionJob DescriptionLook for someone who's having good experience in Radiochemistry.Job Role: GMP Manufacturing TechnicianLocation: Watertown, MA 02472Fulltime RoleReporting: Associate Director, Clinical ManufacturingDescription:We are seeking an experienced GMP Manufacturing Technician, advancing personalized medicine and...
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Associate Director, QC Analytics, Cell Therapy
2 weeks ago
Watertown, United States ElevateBio Full timeElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential. The Role: The...
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Gmp Manufacturing Technician
3 weeks ago
Watertown, United States Mariana Oncology Full time**Reporting**: Associate Director, Clinical Manufacturing **Description**: Mariana Oncology is focused on an extremely exciting field of oncology of precision radiopharmaceuticals to treat unmet need in solid tumors. We are at the vanguard in developing best in class alpha and beta emitting radio ligands targeting cancer tumors while mitigating destruction...
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Associate Director
1 week ago
Watertown, Massachusetts, United States Novo Nordisk Full timeAbout the Department Our Boston Research & Development hub, anchored in the greater Boston area, brings together the best minds in life science innovation. The teams located in facilities in Lexington, Watertown and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future,...
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GMP Manufacturing Technician
2 weeks ago
Watertown, United States Mariana Oncology Full timeReporting Associate Director, Clinical Manufacturing Description Mariana Oncology is focused on an extremely exciting field of oncology of precision radiopharmaceuticals to treat unmet need in solid tumors. We are at the vanguard in developing best in class alpha and beta emitting radio ligands targeting cancer tumors while mitigating destruction to healthy...
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Director of Operations
1 week ago
Watertown, United States Ethanolproducer Full timePost unlimited 30-day online listings with the ethanol Job Package! Unlimited Job Posts for 1 year! Director of Operations Details Job Title Director of Operations Company Location Watertown, SD Job Description & Requirements Job Description Your next career opportunity!As one of the industry leaders Glacial Lakes Energy (GLE), a corn ethanol producer is in...
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GMP Manufacturing Technician
1 month ago
Watertown, United States Mariana Oncology Full timeJob DescriptionJob DescriptionSalary: Reporting:Associate Director, Clinical ManufacturingDescription:Mariana Oncology is focused on an extremely exciting field of oncology of precision radiopharmaceuticals to treat unmet need in solid tumors. We are at the vanguard in developing best in class alpha and beta emitting radio ligands targeting cancer tumors...
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GMP Manufacturing Technician
7 hours ago
Watertown, United States Mariana Oncology Full timeJob DescriptionJob DescriptionSalary: Reporting:Associate Director, Clinical ManufacturingDescription:Mariana Oncology is focused on an extremely exciting field of oncology of precision radiopharmaceuticals to treat unmet need in solid tumors. We are at the vanguard in developing best in class alpha and beta emitting radio ligands targeting cancer tumors...
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Watertown, United States Planet Pharma Full timeLocation: Waltham, MA - 3 days / week onsite Salary: AD - $175K + 20% bonus; Director - $200K+ 22% Bonus Top Skills Proven ability to lead Trial Master File (TMF) strategy, streamline processes, oversee vendor management, and ensure inspection readiness. Strong background in managing vendors effectively. Extensive experience with inspection readiness and...
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Manufacturing Engineer
4 weeks ago
Watertown, United States Persona Signs Full timeJob Type Full-timeDescriptionJob Summary To analyze facility layout, workflow, and work methods in order to initiate, maintain, and improve manufacturing support processes, costs, and controls in the manufacture of product. To help facilitate the construction and operation of a new digital printing facility.Job Responsibilities •Become the facility expert...
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Associate Director, Global Trade Compliance
1 week ago
Watertown, United States Alkermes Full timeJob DescriptionASSOCIATE DIRECTOR , GLOBAL TRADE COMPLIANCE JOB DESCRIPTION Summary The Associate Director, Global Trade Compliance, is responsible for the creation, execution, and management of Alkermes' global trade strategies and policies. This role will provide leadership and direction to ensure the development, clinical, and commercial trade routes and...
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Associate Director, Global Trade Compliance
4 hours ago
Watertown, United States Alkermes Full timeJob DescriptionASSOCIATE DIRECTOR , GLOBAL TRADE COMPLIANCE JOB DESCRIPTION Summary The Associate Director, Global Trade Compliance, is responsible for the creation, execution, and management of Alkermes' global trade strategies and policies. This role will provide leadership and direction to ensure the development, clinical, and commercial trade routes and...
