BioSpace, Inc.
Senior Manager, CMC Program Management
BioSpace, Inc., San Diego, California, United States, 92189
Job Details
Job Title:
Senior Manager, CMC Program Management
Location:
San Diego, CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Portfolio Strategy & Program ManagementStrive to Bring a Profound Difference to our PatientsAt 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 Manager will work closely with CMC Leadership and subject matter experts (SMEs) to drive effective execution of CMC deliverables through program and project management support. The ideal candidate is highly organized and passionate about contributing to a strong team in a patient-centric environment.
What You Will ContributeProvide program management leadership, support, and facilitation for dynamic, cross-functional CMC TeamsBuild and monitor fully integrated project schedules capturing all manufacturing activities and resources needed in accordance with corporate goals, scope, budget, and risksEstablish strong partnerships with internal and external team members to build high-performing teams that will achieve ambitious goalsLead risk management of CMC programs, proactively identifying risks, developing strategies to address them appropriately, and driving the teams to overcome issues and challengesFacilitate internal and partner/CDMO CMC meetings, including scheduling, developing agendas, writing and distributing meeting summaries, and tracking goals and action items to completionDrive teams to effective decision-making and risk/opportunity scenario planningDevelop and manage CMC programs budgets in coordination with CMC leads and SMEsCreate, organize and maintain CMC documents for access by the project teams and coordinate timely CMC document review/approval to support development, manufacturing, Regulatory and Quality activitiesWork effectively in a fast-paced, matrix environment to integrate CMC team efforts across multiple programsApply Project Management Best Practices and demonstrate a continuous improvement mindset: proactively seek out, recommend, and implement process improvementsImplement new processes and process improvement initiatives designed to improve the efficiency and effectiveness of the Program Management functionWhat We Seek
Advanced degree (MS or PhD) in Life Sciences, chemistry or a related field preferredMinimum of 6 years of cGMP manufacturing program/project management experience in the pharmaceutical or biopharmaceutical industry, with additional CMC technical experience preferredDemonstrated leadership skills with the breadth of professional experience and the drive to work with both internal and external partners to define and implement effective project management plans.Strong understanding of drug development, including in-depth knowledge of CMC functions and the strategic and operational requirements from IND to commercial launchHighly skilled at working collaboratively with cross-functional teams and contractors to drive results and meet company objectives, including ability to influence in a matrix organizationProven ability to manage competing priorities, budgets, and timelines in a fast-paced, rapid-growth environmentKnowledgeable in cGMP manufacturing and CMC regulatory requirements for pharmaceuticalsSelf-directed and proactive with ability to function independently, exercise good judgment and respond quickly and effectively to changing environmentsTechnical proficiency with project management tools; strong computer skills and experience with software such as MS Project, SmartSheet, Excel and SharePointStrong interpersonal, written, and verbal communication skills, with the ability to distill and effectively communicate key messages from complex discussionsExceptional organizational skills and attention to detailProject management skills, along with problem solving, negotiation skills, conflict resolution, influencing skills, and team building skillsPreferred Skills
A background in rare diseases, oligonucleotide or biologics therapeuticsProject Management Professional (PMP) or similar certificationWhat We will Provide to You:
The base salary range for this role is $153,800 - $169,900. 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
Job Title:
Senior Manager, CMC Program Management
Location:
San Diego, CA / Hybrid / Remote
Position type:
FLSA:
Full time
Exempt
Department:
Portfolio Strategy & Program ManagementStrive to Bring a Profound Difference to our PatientsAt 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 Manager will work closely with CMC Leadership and subject matter experts (SMEs) to drive effective execution of CMC deliverables through program and project management support. The ideal candidate is highly organized and passionate about contributing to a strong team in a patient-centric environment.
What You Will ContributeProvide program management leadership, support, and facilitation for dynamic, cross-functional CMC TeamsBuild and monitor fully integrated project schedules capturing all manufacturing activities and resources needed in accordance with corporate goals, scope, budget, and risksEstablish strong partnerships with internal and external team members to build high-performing teams that will achieve ambitious goalsLead risk management of CMC programs, proactively identifying risks, developing strategies to address them appropriately, and driving the teams to overcome issues and challengesFacilitate internal and partner/CDMO CMC meetings, including scheduling, developing agendas, writing and distributing meeting summaries, and tracking goals and action items to completionDrive teams to effective decision-making and risk/opportunity scenario planningDevelop and manage CMC programs budgets in coordination with CMC leads and SMEsCreate, organize and maintain CMC documents for access by the project teams and coordinate timely CMC document review/approval to support development, manufacturing, Regulatory and Quality activitiesWork effectively in a fast-paced, matrix environment to integrate CMC team efforts across multiple programsApply Project Management Best Practices and demonstrate a continuous improvement mindset: proactively seek out, recommend, and implement process improvementsImplement new processes and process improvement initiatives designed to improve the efficiency and effectiveness of the Program Management functionWhat We Seek
Advanced degree (MS or PhD) in Life Sciences, chemistry or a related field preferredMinimum of 6 years of cGMP manufacturing program/project management experience in the pharmaceutical or biopharmaceutical industry, with additional CMC technical experience preferredDemonstrated leadership skills with the breadth of professional experience and the drive to work with both internal and external partners to define and implement effective project management plans.Strong understanding of drug development, including in-depth knowledge of CMC functions and the strategic and operational requirements from IND to commercial launchHighly skilled at working collaboratively with cross-functional teams and contractors to drive results and meet company objectives, including ability to influence in a matrix organizationProven ability to manage competing priorities, budgets, and timelines in a fast-paced, rapid-growth environmentKnowledgeable in cGMP manufacturing and CMC regulatory requirements for pharmaceuticalsSelf-directed and proactive with ability to function independently, exercise good judgment and respond quickly and effectively to changing environmentsTechnical proficiency with project management tools; strong computer skills and experience with software such as MS Project, SmartSheet, Excel and SharePointStrong interpersonal, written, and verbal communication skills, with the ability to distill and effectively communicate key messages from complex discussionsExceptional organizational skills and attention to detailProject management skills, along with problem solving, negotiation skills, conflict resolution, influencing skills, and team building skillsPreferred Skills
A background in rare diseases, oligonucleotide or biologics therapeuticsProject Management Professional (PMP) or similar certificationWhat We will Provide to You:
The base salary range for this role is $153,800 - $169,900. 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