Senior Bioconjugation Process Development and Manufacturing Lead

4 weeks ago

San Diego, California, United States Avidity NanoMedicines Full time
About the Role

We are seeking a highly experienced Associate Director to lead our AOC Process Development and Manufacturing team. As a key member of our Technical Development department, you will be responsible for managing all aspects of AOC drug substance process development and manufacturing, including scale-up to Phase 3 and commercial.

Key Responsibilities
  • Assume technical responsibility for AOC DS CMO process development and manufacturing for one or more programs.
  • Provide subject matter expert guidance for AOC DS process development and scale-up.
  • Develop and execute late-stage manufacturing strategy to meet Avidity's advancing pipeline.
  • Work with CMOs and QA to ensure timely release of AOC DS.
  • Work with QC, QA, and Analytics & Formulations to refine AOC DS specifications for late-stage clinical trials and commercialization.
  • Work with CMOs, QA, and Supply Chain to ensure timely delivery of AOC DS to DP manufacturing sites.
  • Provide Person-In-Plant support for AOC DS manufacturing runs.
  • Author relevant sections of Regulatory filings, including INDs, IND amendments, and BLAs.
  • Coordinate AOC DS vendor regulatory support as needed and ensure communication between Avidity RA and AOC DS CMOs.
  • Work with the QC stability team to ensure that AOC DS shelf-life extensions are executed in a timely manner. Provide SME oversight of AOC DS stability programs.
  • Manage AOC DS tech transfer activities between CMOs and/or within CMOs for scale-up.
  • Work with the Analytics & Formulations team to design and manage AOC DS development studies supporting commercial launch.
  • Provide technical support for AOC DS OOS, OOT, deviations, change controls, and nonconformance investigations.
  • Support AOC DS process characterization, validation readiness, and PPQ campaign execution.
  • Identify and communicate risks to clinical programs and commercial supply chain due to manufacturing delays.
  • Participate in developing appropriate risk mitigation strategies for AOC DS supply.
  • Adhere to applicable regulations, including FDA, EMA, ICH, GCP, GMP, and Avidity policies and procedures.
Requirements
  • Minimum Bachelor's degree in chemistry, chemical engineering, pharmaceutical science, or related field required. Master's or PhD preferred.
  • Minimum of 8 years of pharmaceutical industry experience in antibody/protein bioconjugation, ideally with oligonucleotides.
  • Expertise in bioconjugation process development and manufacture, scale-up, and technology transfer.
  • Prior experience in clinical Phase 3/commercial readiness process development and manufacturing, Process Characterization, and PPQ with knowledge of QA and Regulatory requirements for late-stage clinical and commercial manufacturing.
  • Experience in GMP manufacturing and a strong understanding of US, EU, and JP regulations are required.
  • Prior IND and BLA filing experience.
  • Experience working with third-party CMOs.
  • Knowledge of cGMP, ICH, FDA, and EMA guidelines regarding ADCs or similar platforms.
  • Proven track record of effective internal and external collaboration.
  • Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem-solving.
  • Ability to multi-task, manage conflict, and work in a fast-paced environment.
What We Offer
  • The base salary range for this role is $167,000 - $194,000. The final compensation will be commensurate with relevant experience, skillset, internal equity, and market factors.
  • Avidity offers competitive compensation and benefits, including the opportunity for annual and spot bonuses, stock options, and RSUs, as well as a 401(k) with an employer match.
  • A commitment to learning and development, which includes a variety of programming internally developed by and for Avidity employees, opportunities for job-specific training offered by industry, and an education reimbursement program.

  • Senior Director, Bioconjugation Process Development and Manufacturing

    4 weeks ago

    San Diego, California, United States BioSpace, Inc. Full time

    About the RoleWe are seeking a highly skilled Associate Director to lead our AOC Process Development and Manufacturing team. As a key member of our Technical Development department, you will be responsible for managing all aspects of AOC drug substance process development and manufacturing, including scale-up to Phase 3 and commercial.Key...

  • Senior Process Development Engineer

    4 weeks ago

    San Diego, California, United States Halozyme Full time

    Senior Process Development EngineerAt Halozyme, we are seeking a highly skilled Senior Process Development Engineer to join our team. As a key contributor in protein process technology transfer, laboratory management, and process validation, you will play a critical role in the development and implementation of our manufacturing processes.Key...

  • CMC API Process Development and Manufacturing Lead

    1 month ago

    San Diego, California, United States Kumquat Biosciences Inc Full time

    Job SummaryKumquat Biosciences is a biotechnology company dedicated to the discovery and development of innovative drugs to transform cancer treatments. We are seeking a highly motivated and experienced CMC drug substance professional to join our CMC team in San Diego.This candidate will report to the senior director and head of CMC and work closely with our...

  • Senior Technical Lead for Manufacturing Processes

    4 weeks ago

    San Jose, California, United States MILLENNIUMSOFT Full time

    Job SummaryWe are seeking a skilled Senior Manufacturing Engineer to join our team at MillenniumSoft. The ideal candidate will have a strong background in manufacturing engineering, with experience in leading cross-functional teams and implementing process improvements. This is a challenging and rewarding role that requires strong technical expertise,...

  • Senior Fermentation Process Development Expert

    5 days ago

    San Diego, California, United States Web-atrio Full time

    Job SummaryWe are seeking a Senior Fermentation Process Development Expert to join our team at Web-atrio. This is an exceptional opportunity for a highly skilled professional to drive biologics manufacturing process optimization and scale-up.About the RoleThe successful candidate will act as a primary driver in biologics manufacturing process optimization,...

  • Manufacturing Engineering Lead

    4 weeks ago

    San Diego, California, United States Parker Hannifin Corporation Full time

    Job SummaryWe are seeking a highly skilled Senior Manufacturing Engineer to join our team at Parker Hannifin Corporation. As a key member of our manufacturing team, you will be responsible for planning, developing, and implementing manufacturing methods, processes, and operations for new and existing composite aerospace products and assemblies.Key...

  • Manufacturing Process Engineer

    4 weeks ago

    San Diego, California, United States Volt Full time

    Volt is seeking a skilled Manufacturing Engineer to join their team in San Diego, CA. As an Associate Manufacturing Engineer, you will be responsible for manufacturing planning, process improvement, and quality control.Key Responsibilities:Develop detailed manufacturing plans and process requirements.Lead production quality investigations and...

  • Senior Director of Formulation Development

    4 weeks ago

    South San Francisco, California, United States SonoThera Full time

    About SonoThera: SonoThera is a pioneering biopharmaceutical company that has developed a cutting-edge ultrasound-guided non-viral gene therapy platform to provide patients with the next generation of genetic medicines. Our platform can precisely and non-invasively target almost any organ in the body to deliver large payloads of diverse formats (DNA, RNA,...

  • Senior Process Development Engineer

    1 month ago

    San Diego, California, United States Leonardo DRS Full time

    Job SummaryThe Process Development Engineer at Daylight Solutions will be responsible for supporting the development of laser modules from initial design through production. This includes manufacturing analysis, fixture development, and integration of robotic tooling. The ideal candidate will have a strong understanding of equipment, documentation, and...

  • Senior Process Development Engineer

    4 weeks ago

    San Diego, California, United States SES Government Solutions Full time

    Job SummaryThe Process Development Engineer at SES Government Solutions will be responsible for supporting the development of laser modules from initial design through production. This includes manufacturing analysis, fixture development, and integration of robotic tooling. The ideal candidate will have a strong understanding of equipment, documentation, and...

  • Manufacturing Process Sustainment Manager

    4 weeks ago

    San Diego, California, United States Hologic Full time

    Hologic is seeking a skilled and experienced Manufacturing Process Sustainment Manager to join our Operations team. This is a key role that will play a critical part in ensuring the success of our Molecular Diagnostic and Lateral Flow commercialized products.The successful candidate will be responsible for leading a team focused on the creation, validation,...

  • Senior Manufacturing Science and Technology Expert

    4 weeks ago

    San Diego, California, United States Wacker Chemie AG Full time

    We are seeking a highly skilled Senior Manufacturing Science and Technology Expert to join our team at Wacker Chemie AG. As a key member of our manufacturing operations, you will be responsible for supporting the development and implementation of new manufacturing processes and technologies.The ideal candidate will have a strong background in chemical...

  • Manufacturing Process Improvement Engineer

    4 weeks ago

    San Diego, California, United States Actalent Full time

    Job Title: Manufacturing Engineer II Job DescriptionThe Manufacturing Engineer II will develop engineering solutions to improve the manufacturing process for new and existing aerospace products. This role requires problem-solving skills using existing procedures and data analysis to make informed engineering judgments. Collaborating with design teams and...

  • Manufacturing Process Improvement Engineer

    4 weeks ago

    San Diego, California, United States Actalent Full time

    Job Title: Manufacturing Engineer IIIThe Manufacturing Engineer III will develop engineering solutions to enhance the manufacturing process for new and existing aerospace products. Problem-solving will be conducted using existing procedures along with data analysis to make informed engineering decisions.Collaborate with design teams and value stream leads to...

  • Manufacturing Process Improvement Specialist

    4 weeks ago

    San Diego, California, United States Revvity Full time

    Job SummaryThe Manufacturing Engineer I will play a key role in driving continuous improvement activities in Manufacturing and across Operations. This position will lead the efforts to optimize business processes and systems by assessing business needs and proposing, developing, and implementing equipment, process, procedural and software solutions and...

  • Manufacturing Engineer

    4 weeks ago

    San Diego, California, United States Resonetics Full time

    Job Title: Manufacturing Engineer - Process OptimizationJob Summary:Resonetics is a global leader in advanced engineering, prototyping, product development, and micro-manufacturing, driving innovation in the medical device industry. As we rapidly expand across all our locations, we continue to push the boundaries of technology while fostering a dynamic,...

  • Senior Manufacturing Engineer

    4 weeks ago

    San Diego, California, United States KnowHireMatch Full time

    KnowHireMatch is seeking a Senior Manufacturing Engineer in San Diego to enhance the production processes of a leading developer of custom lasers for applications like biomedical instrumentation and holography.Key Responsibilities:Develop, evaluate, and document efficient manufacturing methods based on engineering specifications.Establish key production...

  • Manufacturing Engineering Director

    4 weeks ago

    San Diego, California, United States General Dynamics - Ordnance and Tactical Systems (CA) Full time

    Job SummaryGeneral Dynamics - Ordnance and Tactical Systems (CA) is seeking a skilled Manufacturing Engineering Manager to lead the development and implementation of industrial manufacturing processes. The ideal candidate will have a strong background in manufacturing engineering, leadership skills, and experience in a relevant function.Key...

  • Manufacturing Process Engineer

    4 weeks ago

    San Diego, California, United States US Tech Solutions Full time

    Job Title: Manufacturing Process EngineerJob Summary:US Tech Solutions is seeking a skilled Manufacturing Process Engineer to support the assembly, test, certification, and shipment of our optical, resistivity, and thin-film thickness measurement systems. The ideal candidate will have experience in developing production documentation, manufacturing...

  • Senior Manufacturing Engineer

    4 weeks ago

    San Diego, California, United States Parker Hannifin Corporation Full time

    Job DescriptionAt Parker Hannifin Corporation, we are seeking a highly skilled Senior Manufacturing Engineer to join our team. This is a critical role that requires a strong background in manufacturing engineering, with a focus on composite materials and aerospace applications.Key ResponsibilitiesDevelop and implement manufacturing processes for composite...