Manager Oligonucleotide Manufacturing
Manager Oligonucleotide Manufacturing
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1 Vacancy
Job Description
Description
Job Title:
Manager Oligonucleotide Manufacturing
Location:
San Diego CA (preferred) or Remote
Position type:
FLSA:
Finance ID:
Full time
Exempt
7625Q2244
Department:
TD&O
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
We are seeking an experienced and highly energetic person who is interested in helping Avidity grow into a latestage clinical and commercial manufacturing company. The person will report to the Senior Director of Oligonucleotides (AOC) Technical Development and support clinical/commercial manufacture of Aviditys current and future AOC programs. The person should have prior handson manufacturing experience and excellent knowledge of oligonucleotide manufacturing process including supporting Change Controls Deviations Investigations Process Scaleup and Tech Transfers.
What You Will Contribute
- Assume responsibility for oligonucleotide manufacturing processes review master and executed batch records and provide subject matter expert (SME) guidance for deviations investigations change controls GMP tech transfers and manufacturing campaigns.
- Perform detailed technical review of batch documents to support the timely release of cGMP batches.
- Be responsible to Tech Transfer documentation and ensure successful transfer of processes to CMOs.
- Provide personinplant support during manufacturing runs and/or campaigns.
- Work with CMOs QA and Supply Chain to ensure timely delivery of oligonucleotide to drug substance (DS) sites in time for DS bioconjugation.
- Support the drug substance (DS) team which is responsible for the manufacture of the AOCs on an asneeded basis.
- Provide CMC support for regulatory filings including INDs CTAs amendments and NDA/BLA as needed.
- Ensure adherence to applicable regulations including FDA EMA PMDA ICH GCP GMP and Avidity policies and procedures.
- Provide PMI and COGM assessments for processes and unit operation scenarios.
- Work with QC QA and Analytics & Formulations to refine oligonucleotide specifications for latestage clinical trials and commercialization.
- Provide technical support for oligonucleotide OOS OOT deviations change controls and nonconformance investigations.
- Support oligonucleotide process characterization validation readiness and PPQ campaign .
What We Seek
- Bachelors or Masters degree in Chemistry Biochemistry Chemical Engineering or related field required.
- A minimum of 7 years of relevant industry experience in manufacture of oligonucleotide. The person should have:
- Experience with largescale oligonucleotide manufacturing including synthesis downstream purification annealing and additional processing
- Experience supporting deviations investigations change controls batch record reviews and process tech transfers
- Onthefloor GMP manufacturing experience
- Prior experience in clinical pivotal/commercial readiness process development and manufacturing process characterization control strategy and PPQ with knowledge of QA and Regulatory requirements for latestage manufacturing.
- Prior IND and BLA filing experience.
- Be familiar with tools used to evaluate PMI and COGM values.
- Experience working with thirdparty CMOs.
- Proven track record of effective collaboration.
- Excellent communication and interpersonal skills and the ability to facilitate constructive expedient problemsolving.
- Ability to multitask manage conflict and work in a fastpaced environment.
- Must be detailoriented teamoriented collaborative and be able see the big picture.
What We will Provide to You:
- The base salary range for this role is $142.5K$157.5K. 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:
Required Experience:
Manager
Employment Type
Full-Time
