Avidity Biosciences
Manager, Drug Product Development & Manufacturing
Avidity Biosciences, San Diego, California, United States, 92189
Job Title:
Manager, Drug Product Development & Manufacturing
Location:
Hybrid or Remote
Position type:
FLSA:
Full time
Exempt
Department
:
TD&O
Strive to Bring a
Profound Difference to our PatientsAt Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.
Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.
The Opportunity
Manager Drug Product Development and Manufacturing is experienced, highly energetic, and self-motivated. The individual will be responsible for working with existing and new drug product to ensure robust development data packages for regulatory submissions. In addition, the Manager Drug Product Development and Manufacturing will support all aspects of non-GMP and GMP drug product manufacturing and ensure that the CMC team is aligned with the manufacturing strategy at each CMO. A strong knowledge of sterile parenteral filling and the requirements of clinical supply manufacturing is required as well as a working knowledge of cGMP and FDA/EMA guidelines. The Manager Drug Product Development and Manufacturing will support the authoring and reviewing of module 3 IND and BLA sections related to drug product.
What You Will Contribute
Manage daily technical activities for Avidity’s drug product CMOs related to clinical and commercial drug product lifecycle management programs, which may include cross-functional team leadership.
Work with CMOs and QA to ensure timely release of DP.
Spearhead technical review of drug product executed batch records, deviations, change controls, nonconformance investigations, etc.
Identify and communicate risks to clinical programs due to manufacturing delays.
Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.
Work with CMOs, QA and supply chain to ensure timely delivery of drug substance to drug product sites in time for DP manufacturing.
Provide Person-In-Plant support for drug product manufacturing runs.
Provide CMC support for regulatory filings including INDs, IND amendments and NDA/BLAs as needed. Coordinate DP vendor regulatory support and ensure communication between Avidity RA and DP CMOs.
Work with the QC stability team to ensure that expiry and retest dating is current and fully aligned with the drug product supply plan.
Manage tech transfer activities between CMOs and/or within CMOs for scale-up of new or existing drug products.
Lead or support characterization, validation, and comparability studies; includes process characterization studies, container closure selection, leachable/extractables, freeze/thaw studies, photo degradation, product process qualification, and other BLA-enabling work.
What We Seek
Minimum 5+ years with BS or PhD (preferred) in pharmaceutical sciences, engineering, or related field required.
Experience in GMP manufacturing required, along with strong understanding of US and EU regulations.
Experience working with third-party CMOs required.
Knowledge of cGMP, ICH, FDA, EMA guidelines regarding drug product supply.
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
Will Provide to You:
The base salary range for this role is $129,000 - $163,000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
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.
Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego, CA
92121
O: 858-401-7900
F: 858-401-7901
#J-18808-Ljbffr
Manager, Drug Product Development & Manufacturing
Location:
Hybrid or Remote
Position type:
FLSA:
Full time
Exempt
Department
:
TD&O
Strive to Bring a
Profound Difference to our PatientsAt Avidity Biosciences, we are passionate about the impact of every employee in realizing our vision of improving people’s lives by delivering a new class of RNA therapeutics. Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. If you are a committed, solution-oriented thinker, join us in making a difference and become part of our growing culture that is integrated, collaborative, agile and focused on the needs of patients.
Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare muscle diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is broadening the reach of AOCs with its advancing and expanding pipeline, including programs in cardiology and immunology through internal discovery efforts and key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline, and people, please visit www.aviditybiosciences.com and engage with us on LinkedIn and Twitter.
The Opportunity
Manager Drug Product Development and Manufacturing is experienced, highly energetic, and self-motivated. The individual will be responsible for working with existing and new drug product to ensure robust development data packages for regulatory submissions. In addition, the Manager Drug Product Development and Manufacturing will support all aspects of non-GMP and GMP drug product manufacturing and ensure that the CMC team is aligned with the manufacturing strategy at each CMO. A strong knowledge of sterile parenteral filling and the requirements of clinical supply manufacturing is required as well as a working knowledge of cGMP and FDA/EMA guidelines. The Manager Drug Product Development and Manufacturing will support the authoring and reviewing of module 3 IND and BLA sections related to drug product.
What You Will Contribute
Manage daily technical activities for Avidity’s drug product CMOs related to clinical and commercial drug product lifecycle management programs, which may include cross-functional team leadership.
Work with CMOs and QA to ensure timely release of DP.
Spearhead technical review of drug product executed batch records, deviations, change controls, nonconformance investigations, etc.
Identify and communicate risks to clinical programs due to manufacturing delays.
Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.
Work with CMOs, QA and supply chain to ensure timely delivery of drug substance to drug product sites in time for DP manufacturing.
Provide Person-In-Plant support for drug product manufacturing runs.
Provide CMC support for regulatory filings including INDs, IND amendments and NDA/BLAs as needed. Coordinate DP vendor regulatory support and ensure communication between Avidity RA and DP CMOs.
Work with the QC stability team to ensure that expiry and retest dating is current and fully aligned with the drug product supply plan.
Manage tech transfer activities between CMOs and/or within CMOs for scale-up of new or existing drug products.
Lead or support characterization, validation, and comparability studies; includes process characterization studies, container closure selection, leachable/extractables, freeze/thaw studies, photo degradation, product process qualification, and other BLA-enabling work.
What We Seek
Minimum 5+ years with BS or PhD (preferred) in pharmaceutical sciences, engineering, or related field required.
Experience in GMP manufacturing required, along with strong understanding of US and EU regulations.
Experience working with third-party CMOs required.
Knowledge of cGMP, ICH, FDA, EMA guidelines regarding drug product supply.
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
Will Provide to You:
The base salary range for this role is $129,000 - $163,000. The final compensation will be commensurate with such factors as relevant experience, skillset, internal equity and market factors.
Avidity offers competitive compensation and benefits which includes the opportunity for annual and spot bonuses, stock options and RSUs, as well as a 401(k) with an employer match. In addition, the comprehensive wellness program includes coverage for medical, dental, vision, and LTD, and four weeks of time off.
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.
Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego, CA
92121
O: 858-401-7900
F: 858-401-7901
#J-18808-Ljbffr