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Sr. Director – CMC, Biologics, & New Technology

Position Overview:

 

The Senior Director, New Technologies is responsible for defining and building CMC analytical and formulation platform technologies to support Wolfe Laboratories’ (WL) clients’ emerging therapeutic modalities dosage form development. The Senior Director, New Technologies is responsible for contributing to Wolfe Laboratories’ marketing and sales strategy implementation as it relates to oligonucleotide and biologics services, will serve as subject matter expert during sales presentations, and will cultivate high value client relationships. The Senior Director, New Technologies will direct staff and oversee project management for client CMC development projects, and will monitor revenue, expenses and resource allocation.

In collaboration with other WL leadership, the Senior Director, New Technologies 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 WL’s client services for novel and/or complex therapeutic modalities
  • Responsible for contributing to annual and long-term budgets in collaboration with the WL leadership team
  • Responsible for profit and loss of client services, adjusting short-term forecasts in response to performance

New Technology Development – Approximately 40 %

  • Collect data on emerging therapeutic modalities, drug delivery technologies, analytical methodologies, regulatory requirements, clients, competitors, and the market place to determine areas for future expansion.  Consolidate the information into actionable items, reports and presentations
  • Collaborate with Senior Management to establish business objectives for market and/or service offering expansion.
  • Define specific scientific programs for New Technology Development. Ensure availability of budget, staff, equipment and know-how. Write, solicit and/or review proposed projects from technical staff, ensuring clear and timely deliverables that can be leveraged by marketing, sales and operations
  • Direct dedicated scientific team to execute on approved internal new capabilities development programs, providing scientific guidance and managerial accountability. Build platform capabilities, workflows and institutional knowledge that can be leveraged by other scientific staff within WL and PLS
  • Prepare presentations, white papers, technical data sheets and other marketing materials to showcase the capabilities to attract new customers
  • Attend and present (as appropriate) at targeted technical meetings

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 complex and novel therapeutics modalities projects, ensuring that scientific content and proposal pricing are consistent with established practices in the WL organization.

 

QUALIFICATION REQUIREMENTS

 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

 

Education and Experience

  • Ph.D. in the life sciences with dissertation, publications, postdoctoral experience, and a minimum of 10-12 years industry experience with at least 7 years of leadership/management experience in the pharmaceutical/biotech industry
  • Recognized leader and expert with a track record for advancing new molecular entities, including oligonucleotides and/or biologics and drug delivery systems from early CMC development through commercialization
  • Track record of accomplishment in the development of oligonucleotides and biologics in various dosage forms, including parenterals and enabling formulations, as evidenced by quality and quantity of publications/inventions; expert in developing analytical and characterization methods to support novel 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.