Manager, Quality Control
Manager, Quality Control
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Salary Not Disclosed
1 Vacancy
Job Description
Description
Job Title:
Manager Quality Control
Location:
San Diego CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Finance ID:
CMC/Technical Operations
7625Q22427
Strive to Bring a Profound Difference to our Patients
At Avidity Biosciences we are passionate about the impact of every employee in realizing our vision of improving peoples 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 solutionoriented 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 peoples lives by delivering a new class of RNA therapeutics Antibody Oligonucleotide Conjugates (AOCs). Utilizing its proprietary AOC platform Avidity demonstrated the firstever 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 inSan Diego CA.For more information about our AOC platform clinical development pipeline and people please visitand engage with us onLinkedInandTwitter.
The Opportunity
The Quality Control Manager will support Quality Control aspects for GMP Operations in all phases of product development. The primary function of the position will be accountability for external QC analytical and microbiology activities to support the release and stability testing of Avidity products produced and tested at CMO/CTOs. The candidate will be Aviditys primary analytical and microbiological point of contact for managing selective CMO/CTOs which manufacture and test Aviditys materials (intermediates drug substances and drug products). Excellent verbal and written communication skills are essential for success in this position including extensive experience successfully managing multiple CTOs and CMOs. This role will support the development of QC systems and procedures and continue building relationships with our CMO/CTO network. The candidate will interface with Quality Assurance Supply Chain Manufacturing Analytical Development Regulatory and other crossfunctional teams as required. The position will report to the Associate Director of Quality Control and be a part of Aviditys growing CMC/Technical Operations team.
What You Will Contribute
- Provide oversight of QC activities at external CMOs/CTOs.
- Be the point of contact for selective CMOs/CTOs from initiation of vendor contact through release and stability testing.
- Support analytical technology transfers to CTOs and CMOs and interface with Aviditys analytical and process development teams to facilitate technology transfers.
- Enable testing activities within Aviditys CMO and CTO network to support release and stability of intermediates drug substance and drug product.
- Support the QC team with development of systems and tools for ensuring supply of critical reagents reference standards and controls at CMOs/CTOs.
- Work with the QC team to support development of systems/tools KPIs and databases to track and review release and control data to ensure ease of data reporting and ensure appropriate analytical performance.
- Proactively identify and troubleshoot issues to prevent missed timelines and identify opportunities for improvement of QC operations at CMOs/CTOs.
- Drive from EndtoEnd deviation/OOS investigations as it relates to analytical and microbiological QC testing and implement CAPAs and change controls.
- Hold CMOs/CTOs accountable to deliver on contractual requirements and data delivery for release and stability testing.
- Work with QA to ensure CMOs and CTOs are adhering with appropriate GMP compliance as it relates to testing data integrity and deviation/investigation content.
- Communicate data both verbally at group meetings CMC teams and through written documents and reports.
- Author review and/or approve product specifications SOPs policies risk assessments and technical reports.
- Support of cGMP operations including technical review of change control documentation and reports deviations OOSs and other manufacturing and laboratory investigations.
- Work with project leads to address delays and escalate when necessary.
- Assist in the preparation of CMC regulatory submissions.
- Support other QC activities and projects as needed.
- This position may require travel (510%).
What We Seek
The ideal candidate for this position will have extensive QC experience in a cGMP biologics regulated manufacturing environment is required. The role will interface with Quality Assurance Supply Chain Manufacturing Analytical Development and Regulatory groups to ensure company procedures and industry guidelines are followed. A strong technical background and proven track record in Quality Control related to biologics oligonucleotides and AOC (Antibody Oligonucleotide Conjugate)/ADC modalities.
- BS or MS in a Chemistry Biochemistry Microbiology Biology or other related field
- 5 years of related experience within the biopharmaceutical industry in QC management.
- Working knowledge of bioassay/ELISA antibody antibody drug conjugates oligonucleotides and protein analytical methods is strongly preferred.
- Demonstrated knowledge of cGMP/ICH/FDA/EU/PMDA regulations
- Demonstrated knowledge of USP EP and JP monographs
- Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
- A passion for addressing the critical unmet medical needs of patients
- Selfdirected individual who is able to work with limited direction in a fastpaced goaloriented environment
- Ability to organize data and identify gaps
- Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
- Experience of managing CMO relationships and projects
- Sound understanding and demonstrated application of statistical methods/tools
- Excellent interpersonal skills outstanding organizational skills and excellent written and oral communication skills.
What We will Provide to You:
- The base salary range for this role is $140k $160k. 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 jobspecific training offered by industry and an education reimbursement program.
Avidity Biosciences
10578 Science Center Dr. Suite 125
San Diego CA
92121
O:
F:
#LIDNI
Required Experience:
Manager
Employment Type
Full-Time
