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Research Associate I (In Vitro Biology)

BIOAGE LABS

BIOAGE LABS

Richmond, VA, USA
Posted on Saturday, May 4, 2024
Description

Vice President, CMC

BioAge is a clinical-stage biotechnology company that is harnessing the biology of human aging to develop novel targets and therapies for metabolic diseases.

We are seeking an experienced Vice President, CMC to lead the development and implementation of phase appropriate CMC strategies from early clinical to commercial stages

The Role: This role will monitor and address all CMC related risks and challenges and ensure continuous awareness and escalation where needed with organizational leadership. As a Senior level leader, they will ensure oversight for preclinical, clinical, and commercial supply, and subsequent trials as part of the CMC strategy. The VP of CMC will be expected to support any CMC related due diligence, have oversight of activities at contract development and manufacturing organizations (CDMOs), and participate in authoring/reviewing any relevant documents and submissions to regulatory agencies. This role reports to the Chief Medical Officer.

You: You will bring significant experience and a proven track record of success in the Establishment and oversight of all CMC related activities, including process optimization, solid-state and formulation development, API and drug product manufacturing at external laboratories and manufacturing facilities. You enjoy mentoring staff and have exceptional leadership and management skills. You will also have recent experience in the global submission preparation and maintenance of CMC sections of regulatory filings (e.g., IND/CTA, NDA/MAA). You pride yourself on building strong working relationships with your peers and colleagues and strive for open and transparent communication.

Essential Job Duties:

  • Develops, leads, and executes the CMC strategies from preclinical development to commercialization
  • Has overall responsibility for all API and drug product activities from pre-clinical development through phase 3 registrational products as well as in the postapproval arena. Proactively identifies risks and issues in CMC projects and develops solutions driving through resolution.
  • Identifies Critical Quality Attributes of materials and implements Quality by Design principles for development
  • Identifies, selects and manages CDMOs and consultants in support of ongoing programs including defining scope of work and work orders
  • Supports investigational product (IP) related activities as needed internally for patent applications
  • Collaborates with other function to include CMC requirements in integrated product development plans and target product profiles
  • In coordination with Quality Assurance, implements stage-appropriate analytical methods and protocols and ensure that all CDMOs are using systems and processes in compliance with GMP standards
  • Plans, authors and reviews documents related to CMC sections for regulatory filings.
  • Manages the reviews cGMP batch records and comments for GMP release
  • Develops and executes supply planning for preclinical, clinical, and commercial supply
  • Creates and oversees budgets that ensure the company has all the resources required to meet its objectives within agreed financial parameters
  • Develops and maintains all necessary systems and procedures to ensure the company's operations comply with all regulatory requirements and meet cGMP standards
  • Partners with quality function to drive quality mindset on all aspects including GLP, GCP, cGMP, ICH, regulatory body(ies), national, and local requirements
  • Prepares Requests for Proposals for CDMO/CMO selection in accordance with budget and corporate timelines
  • Provides day-to-day leadership, scientific oversight, and management of the CMC Team and its CDMO relationships
  • Manages/leads CMC regulatory strategy and submission packages to support successful regulatory agency submissions
  • Ensures that all vendors are using systems and processes in compliance with all relevant regulatory standards
  • Represents CMC team with alignment to other functions and third parties at internal/external meetings
  • Manages supply chain and logistics in support of preclinical and clinical studies and commercial operations
  • Leads, prepares, reviews, edits, and approves CMC work protocols, cGMP batch records, CMC regulatory, and quality documents
  • Identifies and leads key process problem resolution activities and process improvement initiatives for CMC
  • Promotes a culture of continuous improvement and high-performance teamwork
  • Continually seeks and implements process development best-practice methodologies

Required Skills and Abilities:

  • A seasoned pharma/biotech leader with an outstanding record of accomplishment in small molecule drug substance and drug product development and manufacturing
  • A robust understanding of cGMP, quality, and regulatory requirements, including preparing and writing crucial sections of regulatory documents (such as NDAs, MAAs, and INDs)
  • Ability to work in a collaborative internal team environment as well as with external vendors to ensure manufacturing timelines are met and budgets controlled
  • A proven scientific problem-solver with experience in managing CDMOs/CMO, scientific collaborations, and contracted R&D
  • Extensive knowledge of Chemistry and Pharmaceutics at all phases of drug development is preferred
  • Successful experience in a fast-paced entrepreneurial environment
  • Ability to effectively manage skilled internal staff (direct reports) and consultants
  • Strong English oral and written communication skills and interpersonal skills
  • Strong organizational skills
  • Strong technical judgment with attention to detail
  • Skills to proactively identify and manage potential risks
  • Familiarity with discovery stage projects leading to candidate nomination
  • Familiarity with ChemDraw and Smartsheets or equivalent tools
  • Proficiency in software applications (Excel, Word, PowerPoint, Project, etc.)

Education and Qualifications:

  • Ph.D. degree in Pharmaceutical Science or Engineering
  • 15+ years of experience in the biotechnology and/or pharmaceutical industry and 5+ years of overseeing CMC teams in all stages from preclinical to commercialization
  • Proven experience in creating CMC strategic plans and implementation
  • Experience in supporting projects in clinical development through commercialization, including process validation and optimization.

Physical Requirements:

  • Travel may vary up to 25% based on needs, and may be domestic or international.

Our company

BioAge is a clinical-stage biotechnology company that is harnessing the biology of human aging to develop novel targets and therapies for metabolic diseases. The company’s lead program, azelaprag, is a potential first-in-class oral APJ agonist entering Phase 2 trials in combination with tirzepatide for the treatment of obesity in older adults. Azelaprag has the potential as an oral regimen to amplify weight loss and improve body composition in patients on obesity therapy with incretin drugs. BioAge’s preclinical programs address key pathways in metabolic aging, based on novel insights from its discovery platform built on human longevity data. To date, BioAge has raised more than $300 million from a top-tier syndicate of investors and pharma companies.

Our workplace

BioAge offers competitive salary, a comprehensive compensation package, and generous paid time off in addition to company-observed holidays. We provide comprehensive health and wellness benefits (medical, dental, and vision insurance) and a 401(k) retirement savings plan with matching employer contributions, and we support families through childcare and fertility benefits. We also pride ourselves in giving employees many opportunities for career development, including a generous annual budget for continued learning and a dedication to training and skill development. The salary for this role is expected to be approximately $275,000 - $325,000 for someone who meets all of the minimum qualifications as listed for the role, and may be adjusted accordingly for someone with more or less experience as a Vice President or Senior Vice President. We are open to the concept that different experience levels add value to the team in different ways, and therefore will consider a variety of experience and offer commensurate pay.

At BioAge, we embrace diversity and differences while we learn from each other, and we believe that every team member has an important role to play. We are an equal opportunity employer. BioAge prohibits discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. BioAge conforms to the spirit as well as to the letter of all applicable laws and regulations.