Senior Director, Technical Product
Senior Director, Technical Product
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Salary Not Disclosed
1 Vacancy
Job Description
Description
Job Title:
Senior Director Technical Product
Location:
San Diego CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Finance ID:
TD&O
7625Q2243
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 Senior Director Technical Product Lead (TPL) is a senior leader within the Technical Development Department responsible for representing the CMC matrix on multiple program teams in our expanding pipeline and sitting on Program Teams as the Tech Ops representative. This TPL will also be responsible for establishing the Technical Development Strategy team which will manage the Tech Ops Leadership for all programs in the pipeline and standardize TPL ways of working. The ideal candidate will bring a strong knowledge of CMC Leadership with deep technical understanding of Oligonucleotide and/or Bioconjugation process development tech transfer manufacturing CMC regulatory strategy and Agency interactions. The Senior Director Technical Product Lead will be responsible for the crossfunctional review of IND/IMPDs BLA represent CMC in interactions with Regulatory Agencies and interfacing with Third Party development and manufacturing.
What You Will Contribute
- Head and build out the Technical Development Strategy Function
- Crossfunctional Tech Ops Lead member of Program Core Team for 1 or 2 latephase and 1 or 2 earlyphase programs
- Responsible for Tech Ops Strategy for program and represents Tech Ops at the Program level
- Crossfunctional review of all Tech Ops docs including:
- IND/IMPD RTQs and other regulatory documents
- Representative in Regulatory Interactions
- Scale up and tech transfer protocols
- Pharmacy Manual
- Comparability package
- Specifications
- PC/PV documentation
- Close interactions with clinical supply and clinical/commercial manufacturing planning
- Presenting Program Stage Gate at the Steering Committees
- Present Tech Ops strategy in Program governance
- Author and review relevant sections of Regulatory filings including INDs IND amendments and BLAs.
- Identify and communicate risks to clinical programs and commercial supply chain due to process and manufacturing delays.
- Participate in developing appropriate risk mitigation strategies for Tech Ops activities.
- Adhere to applicable regulations including FDA EMA ICH GCP GMP and Avidity policies and procedures.
What We Seek
- MinimumBachelors degree in chemistry chemical engineering pharmaceutical science or related field required. Masters or PhD preferred.
- Minimum of 12 years of pharmaceutical industry experience in bioprocess or oligonucleotide PD and Manufacturing.
- Minimum of 6 years of pharmaceutical industry experience in a CMC leadership role for a biologics or oligonucleotide mid to latephase program.
- Prior experience in clinical Phase 3/commercial readiness process development and manufacturing Process Characterization and PPQ with knowledge of QA and Regulatory requirements for latestage clinical and commercial manufacturing.
- Experience working with thirdparty CDMOs.
- Prior IND and BLA/NDA filing experience.
- Knowledge of cGMP ICH FDA and EMA guidelines.
- Proven track record of effective internal and external 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.
What We Will Provide to You:
- The base salary range for this role is $261250$288000. The final compensation will be commensurate with relevant experience skillset internal equity and market factors.
- Avidity offers competitive compensation and benefits including 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:
Exec
Employment Type
Full-Time
