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Vice President – CMC, Small Molecules

Position Overview:

 

The Vice President, CMC Small Molecules is responsible for leading and growing the small molecule CMC development function of the Wolfe Laboratories subsidiary of Pace Analytical Life Sciences (PLS). The Vice President, CMC Small Molecules is responsible for contributing to Wolfe Laboratories’ marketing and sales strategy implementation as it relates to small molecule services, will serve as subject matter expert during sales presentations, and will cultivate high value client relationships. The Vice President, CMC Small Molecules will direct staff and oversee project management of the CMC Small Molecule function, and will monitor revenue, expenses and resource allocation. In collaboration with other WL leadership, the Vice President, CMC Small Molecules will create short- and long-term plans and budgets that are aligned with the WL strategy.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

 

Essential duties include the following. Other duties may be assigned as needed.

 

Financial – Approximately 15 %

  • Responsible for achieving annual revenue and EBITDA targets for the Small Molecule CMC function of WL
  • Responsible for contributing to annual and long-term budgets in collaboration with the WL leadership team
  • Responsible for profit and loss of the Small Molecule CMC function of WL, adjusting short-term forecasts in response to performance

Management / Leadership – Approximately 40 %

  • Lead the Small Molecule CMC function, consisting of analytical development, pre-formulation, formulation development, and process development. Stay current with advances in the scientific literature and specifically in Small Molecules pharmaceutical development
  • Oversee the sales, proposal writing, pricing and project management of our clients’ complex CMC development projects for Small Molecules. Collaborate with internal functions and clients to negotiate and win contracts.
  • Identify, guide, mentor, set goals and manage talent; provide real-time feedback to scientists for performance management and career development.  Ensure team has appropriate attitudes, skills, capabilities and resources to meet current and future business needs.  Build the function to support ongoing organizational needs.  Ensure that entire team understands and embraces WL core values of integrity, excellence and teamwork, the vision and mission of WL
  • Provide scientific guidance and oversight while factoring in technical, regulatory and intellectual property considerations and risk assessments
  • Ensure all development and validation activities are completed in accordance with quality and regulatory expectations to support clients’ global regulatory submissions 
  • Review Technical/Quality agreements to ensure that project activities are conducted with the appropriate level of scientific and regulatory compliance
  • Support CMC staff in selection and management of consultants, contractors, suppliers, vendors and any sub-contracted activities

Management / Leadership – Approximately 30 %

  • Direct and/or supervise the direction of clients’ CMC development projects for complex and novel therapeutic modalities, consisting of analytical development, pre-formulation, formulation development, and process development. Stay current with advances in the scientific literature and specifically in oligonucleotide and biologics pharmaceutical development
  • Oversee the sales, proposal writing, pricing and project management of our clients’ complex CMC development projects for oligonucleotides, biologics and novel therapeutic modalities. Collaborate with internal functions and clients to negotiate and win contracts.
  • Identify, guide, mentor, set goals and manage talent; provide real-time feedback to scientists for performance management and career development.  Ensure team has appropriate attitudes, skills, capabilities and resources to meet current and future business needs.  Build the function to support ongoing organizational needs.  Ensure that entire team understands and embraces WL core values of integrity, excellence and teamwork, the vision and mission of WL
  • Provide scientific guidance and oversight while factoring in technical, regulatory and intellectual property considerations and risk assessments
  • Ensure all development and validation activities are completed in accordance with quality and regulatory expectations to support clients’ global regulatory submissions 
  • Review Technical/Quality agreements to ensure that project activities are conducted with the appropriate level of scientific and regulatory compliance
  • Support CMC staff in selection and management of consultants, contractors, suppliers, vendors and any sub-contracted activities

Operations – Approximately 5%

  • Collaborate with the WL Technical Operations leadership, ensuring that there is staff compliance to and understanding of the differentiating elements of the Technical Operating System: Scientific Training, Project Management, Knowledge Platform, Continuing Education, and Safety
  • Work with managers to prioritize activities within the departments that must be completed to meet individual and project goals.
  • Promote accountability, cooperation and teamwork within the subsidiary and the overall company.

Sales – Approximately 10%

  • Actively participate in the sales process, in collaboration with sales staff, to assist with establishing relationships and/or closing sales opportunities.
  • Lead the proposal writing staff for Small Molecules projects, ensuring that scientific content and proposal pricing are consistent with established practices in the WL organization.

Marketing – Approximately 5%

  • Contribute to the design of technical marketing components and messaging that is consistent with the short- and long-term goals of WL and PLS, and oversee the creation of the specific materials by the technical and marketing staff
  • Attend and present (as appropriate) at targeted technical meetings

Market Research/New Technology – Approximately 5%

  • Collect data on emerging technologies, clients, competitors, and the market place to determine areas for future expansion for the division.  Consolidate the information into actionable items, reports and presentations
  • Collaborate with Senior Management to establish business objectives for market and/or service offering expansion.

 

QUALIFICATION REQUIREMENTS

 

  • Ph.D. in chemistry, materials science, or a related physical science with dissertation, publications, postdoctoral experience, and a minimum of 15 years industry experience with at least 10 years of leadership/management experience in the pharmaceutical/biotech industry
  • Recognized leader and expert with a track record for advancing new chemical entities and drug delivery systems from early CMC development through commercialization
  • Track record of accomplishment in the development of various dosage forms, including parenterals, solids, and enabling formulations, as evidenced by quality and quantity of publications/inventions; expert in developing analytical and characterization methods to support dosage form development
  • Excellent written and verbal communication skills, including preparation, organization, and synthesis of large amounts of data for presentation to internal and external audiences
  • Outstanding problem-solving and organizational skills; thrives in a fast-paced, high-performance, cross-functional team environment
  • Demonstrated ability to build and manage high performing, productive scientific teams
  • Demonstrated proficiency in managerial, administrative and financial skills

     

    Interested candidates are requested to email a copy of their resume with a cover letter to Jill.Wilson@wolfelabs.com.

     

    WHAT WE OFFER

     

    Wolfe Labs’ employees are innovators with a winning attitude. We offer a fun, multi-cultural environment and value teamwork and accountability through a results-oriented, customer-centric focus. We provide generous health and financial benefits, learning opportunities, competitive compensation, the potential to participate in our employee stock option plan, and a wide range of work/life benefits. Candidates who are keen experimentalists, independent thinkers and enthusiastic team players that have a passion for drug development are encouraged to apply.

     

    For more information visit us at: www.wolfelabs.com

     

    Wolfe Laboratories, Inc is an Equal Employment Opportunity employer.