Quality Control Specialist (Raw Materials)

Job Title:

Quality Control Specialist (Raw Materials)

Location:

San Diego, CA / Hybrid / Remote

Position type:

FLSA:

Full time

Exempt

Department:

Finance ID:

Technical Development and Operations

7625-Q224-21

At 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

The Quality Control Specialist (Raw Materials) will develop raw materials strategy, harmonizing raw materials requirements and incoming testing approaches across external manufacturing sites and overseeing vendor material change notification. This role will also contribute to developing systems and procedures, building relationships with our CMO network, and serving as a subject matter expert (SME) for raw materials. The candidate will interface with Quality Assurance, Supply Chain, Manufacturing, Analytical Development, Regulatory, and other cross-functional teams as required. This position will report to Senior QC Manager Raw Material and be a part of Avidity’s growing Technical Development & Operations team.

What You Will Contribute

• Partner with Senior Quality Control Manager (Raw Materials) to develop and implement the raw materials control strategy, ensuring alignment with Avidity procedures and regulatory guidelines.
• Develop and maintain the raw materials specifications per Avidity internal procedure.
• Facilitate technical review of EBRs (Bill of Materials section) in alignment with regulatory submission.
• Contribute to the CMC regulatory submission process by ensuring the accuracy and completeness of raw material documentation.
• Manage the CMOs Vendor Change Notification in alignment with Avidity procedures.
• Support cross functional teams for vendor/supplier issues and vendor selection and qualification.
• Lead or contribute to strategic QC activities and projects related to raw materials as needed.
• Ensure GxP and SOP training tasks are completed in a timely manner.
• This position may require travel (approximately 5%) 

What We Seek

The ideal candidate for this position will have extensive experience with raw material program management. 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, small molecule, 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 managing a raw materials program.
• 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
• Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment
• Ability to organize data and identify gaps
• Knowledge of Good Manufacturing Practices and Good Laboratory Practices.
• Experience in managing CMO relationships and projects is a plus
• Sound understanding and demonstrated application of statistical methods/tools
• Excellent interpersonal skills, outstanding organizational skills, and excellent written and oral communication skills.

• The base salary range for this role is $104,500 - $115,500. 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