Job Title:
Associate Drug Product Process Development Engineer II
Location:
San Diego, CA / Hybrid
Position type:
FLSA:
Full time
Non - Exempt
Department:
Finance ID:
TD&O
-2
Profoundly Improve People's lives by Revolutionizing the Delivery of RNA Therapeutics
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 and engage with us on LinkedIn and X .
The Opportunity
We are seeking a Drug Product Process Development Engineer who is knowledgeable, highly energetic, and self-motivated. The individual will be working with and supporting cross functional project teams on existing and new drug product to ensure robust development data packages for regulatory submissions. In addition, the Drug Product Process Development Engineer will support all aspects of non-GMP and GMP drug product development and manufacturing at external CMOs. 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 first priorities of the Drug Product Process Development Engineer will be to support the project lead on drug product process characterization and technical transfer activities for products manufactured at external CMOs.
What You Will Contribute
- Support project leads on technical activities for Avidity's drug product CMOs related to clinical and commercial parenteral drug product lifecycle management programs, which will include cross-functional team participation.
- Support or draft, as needed, technical protocols for the development of parenteral drug product process including mixing, filling, filtration, lyophilization, and capping.
- Support process characterization studies, container closure selection, leachable/extractables, freeze/thaw studies, photo degradation, product process qualification, and other clinical stage and BLA-enabling work.
- Occasional development lab work may be warranted.
- Collaborate on protocols, manufacturing batch records, sampling and testing plans, and evaluate in-process and applicable analytical data as needed.
- Complete technical review of drug product executed batch records, deviations, change controls, nonconformance investigations, etc, for clinical trial material or development batch 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.
- Support tech transfer activities between CMOs and/or within CMOs for scale-up of new or existing drug products.
- Ensure adherence to applicable regulations including FDA, EMA, ICH, GCP, GMP and Avidity policies and procedures.
What We Seek
- BS in pharmaceutical sciences/engineering with at least 3 years relevant and hands on experience; Masters in pharmaceutical sciences/engineering a plus.
- Strong understanding of drug product GMP manufacturing and pharmaceutical unit operations required, along with understanding of US and EU regulations.
- Experience working with third-party CMOs preferred.
- Quality and attention to detail in documentation work and reports.
- Ability to multi-task, adapt to changing priorities, and work in a fast-paced environment.
- Must be a self-motivated individual requiring little oversight on day-to-day activities.
What We Will Provide To You
- The base salary range for this role is $43.27 - $47.60. 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 include 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
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