Avidity Biosciences
Sr. Director, Commercial Supply Chain
Avidity Biosciences, Los Angeles, California, United States,
Job Title:
Sr. Director, Commercial Supply Chain
Location:
San Diego, CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
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 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 Senior Director, Commercial Supply Chain, is a senior leader accountable for developing and executing a commercial supply chain strategy for Avidity’s first product launches. This position will also be responsible for strategy, planning, sourcing, distribution, ERP, commercial logistics, serialization, and commercial cGMP storage within Technical Development & Operations. This position will work cross-functionally with project management, commercial operations, market access, legal, finance, regulatory affairs, quality assurance, IT, and the broader CMC team as needed. Additionally, this position may serve as the supply chain representative on Avidity’s launch teams and be responsible for building the commercial product supply network globally.
What You Will Contribute
Contribute to the strategic and operational leadership of Avidity’s global supply chain function and disciplines, including demand/supply/capacity planning, sourcing, artwork, inventory management, cold chain shipping, import/export and distribution, and management of Avidity’s external suppliers.
Source and select commercial packaging suppliers in partnership with Drug Product lead(s) and work with DP to ensure packaging occurs within the timeline and budget.
Source, select, and manage third-party logistics (3PL) vendors in partnership with the Commercial/Market Access team.
Manage implementation of the D365 supply module in partnership with Finance and IT.
Set up commercial inventory management system, including month-end close with Finance and year-end cycle counts.
Partner with market access to ensure product delivery as needed to support commercial supply. Develop a robust Demand Management function to review commercial forecasts on a monthly basis.
Assess Avidity’s current QMS/SOPs in relation to supply chain aspects of commercialization.
Assume leadership responsibility for the existing Avidity S&OP process. Highlight supply risks to senior management as needed.
Manage Avidity’s shipping & logistics function, including trade compliance and import/export within Avidity’s supply network.
Manage all aspects of the commercial supply budget.
Manage the Avidity serialization vendor and onboard the team, as needed, to support global serialization requirements.
Manage the Avidity artwork generation process to support commercial packaging in all markets. Partner with Regulatory and Pharmacovigilance to ensure the accuracy of text and approval externally.
Establish commercial inventory targets for all supply nodes (oligo, antibody, conjugate, bulk drug, and finished goods) and manage according to budget and supply forecast.
What We Seek
Bachelor’s Degree required; Advanced Degree preferred.
15+ years of industry experience within a cGMP commercial supply network.
Knowledge of cGMP commercial supply chain infrastructure built within a pharmaceutical 3PL network.
Knowledge of commercial ERP system implementation.
Knowledge of order to cash processes and the requirements of monthly inventory accruals and revenue recognition within the supply network.
Knowledge of appropriate supply SOPs and ability to augment Avidity’s existing QMS with documents needed for commercialization.
Experience managing S&OP and communicating supply risks to senior leadership as needed.
Experience with MS Project and Excel at a minimum. Experience with ERP systems is a plus (Dynamics 365).
Knowledge of import/export regulations, including pro-forma invoice generation and global trade compliance.
Knowledge of cGMP, ICH, FDA, and EMA guidelines regarding temperature-controlled cold chain shipping requirements.
Deep experience with the processes and systems to support compliance with the DSCSA and EU FMD product serialization requirements.
Experience overseeing consistent, reliable, and compliant supply of commercial products in accordance with the forecast and established inventory targets and budget.
Experience working cross-functionally with CMC, Quality, Commercial Operations, Market Access, Legal, and Finance, establishing integrated ways of working to manage and report on the flow of product, information, and cash.
Detailed manufacturing knowledge of oligonucleotides, monoclonal antibodies, drug conjugates, and sterile injectables a plus. The ability to interpret and manage times for delivery is required.
Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills.
Ability to travel as needed for 20% of working hours.
What We Will Provide to You:
The base salary range for this role is $239,000 - $274,000. The final compensation will be commensurate with such factors as 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, including a variety of internal programming 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
#J-18808-Ljbffr
Sr. Director, Commercial Supply Chain
Location:
San Diego, CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
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 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 Senior Director, Commercial Supply Chain, is a senior leader accountable for developing and executing a commercial supply chain strategy for Avidity’s first product launches. This position will also be responsible for strategy, planning, sourcing, distribution, ERP, commercial logistics, serialization, and commercial cGMP storage within Technical Development & Operations. This position will work cross-functionally with project management, commercial operations, market access, legal, finance, regulatory affairs, quality assurance, IT, and the broader CMC team as needed. Additionally, this position may serve as the supply chain representative on Avidity’s launch teams and be responsible for building the commercial product supply network globally.
What You Will Contribute
Contribute to the strategic and operational leadership of Avidity’s global supply chain function and disciplines, including demand/supply/capacity planning, sourcing, artwork, inventory management, cold chain shipping, import/export and distribution, and management of Avidity’s external suppliers.
Source and select commercial packaging suppliers in partnership with Drug Product lead(s) and work with DP to ensure packaging occurs within the timeline and budget.
Source, select, and manage third-party logistics (3PL) vendors in partnership with the Commercial/Market Access team.
Manage implementation of the D365 supply module in partnership with Finance and IT.
Set up commercial inventory management system, including month-end close with Finance and year-end cycle counts.
Partner with market access to ensure product delivery as needed to support commercial supply. Develop a robust Demand Management function to review commercial forecasts on a monthly basis.
Assess Avidity’s current QMS/SOPs in relation to supply chain aspects of commercialization.
Assume leadership responsibility for the existing Avidity S&OP process. Highlight supply risks to senior management as needed.
Manage Avidity’s shipping & logistics function, including trade compliance and import/export within Avidity’s supply network.
Manage all aspects of the commercial supply budget.
Manage the Avidity serialization vendor and onboard the team, as needed, to support global serialization requirements.
Manage the Avidity artwork generation process to support commercial packaging in all markets. Partner with Regulatory and Pharmacovigilance to ensure the accuracy of text and approval externally.
Establish commercial inventory targets for all supply nodes (oligo, antibody, conjugate, bulk drug, and finished goods) and manage according to budget and supply forecast.
What We Seek
Bachelor’s Degree required; Advanced Degree preferred.
15+ years of industry experience within a cGMP commercial supply network.
Knowledge of cGMP commercial supply chain infrastructure built within a pharmaceutical 3PL network.
Knowledge of commercial ERP system implementation.
Knowledge of order to cash processes and the requirements of monthly inventory accruals and revenue recognition within the supply network.
Knowledge of appropriate supply SOPs and ability to augment Avidity’s existing QMS with documents needed for commercialization.
Experience managing S&OP and communicating supply risks to senior leadership as needed.
Experience with MS Project and Excel at a minimum. Experience with ERP systems is a plus (Dynamics 365).
Knowledge of import/export regulations, including pro-forma invoice generation and global trade compliance.
Knowledge of cGMP, ICH, FDA, and EMA guidelines regarding temperature-controlled cold chain shipping requirements.
Deep experience with the processes and systems to support compliance with the DSCSA and EU FMD product serialization requirements.
Experience overseeing consistent, reliable, and compliant supply of commercial products in accordance with the forecast and established inventory targets and budget.
Experience working cross-functionally with CMC, Quality, Commercial Operations, Market Access, Legal, and Finance, establishing integrated ways of working to manage and report on the flow of product, information, and cash.
Detailed manufacturing knowledge of oligonucleotides, monoclonal antibodies, drug conjugates, and sterile injectables a plus. The ability to interpret and manage times for delivery is required.
Demonstrated excellent communication (oral and written), teamwork, organizational, interpersonal, and problem-solving skills.
Ability to travel as needed for 20% of working hours.
What We Will Provide to You:
The base salary range for this role is $239,000 - $274,000. The final compensation will be commensurate with such factors as 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, including a variety of internal programming 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
#J-18808-Ljbffr