• Job Description

  Req#: VPFOR004747

  Purpose and Scope

  Oversees the product development lifecycle from Early Stage exit through regulatory filing and product launch. Oversees development of scientific plans, including the formulation and process development functions. This position functions as the scientific liaison to business partners and thought leaders in areas of interest to the company. This role will provide critical input to the company’s new product strategies and application of its long-acting Injectable technology to meet the growth goals of the company.

  Essential Duties & Responsibilities

  • Serve as a product development leadership team member and act as an internal technical and scientific partner to the Analytical, Clinical, Regulatory, Legal, MS&T, EPMO, Commercial, Quality, Finance, and Business Development functions.
  • Create long-range development plans for the formulation and process development functions in conjunction with other departments to meet the company's growth goals.
  • Define goals per the company strategy and translate these goals into operational project plans.
  • Coordinate, prioritize, and manage pipeline projects from early stage exit through commencement of clinical studies and regulatory filing, ensuring that timelines, resources, and priorities for pipeline projects are delivered promptly.
  • Nurture a culture of innovation, ensuring that technology and formulations achieve novel, effective, and patentable inventions.
  • Hire, train, develop, evaluate, and manage staff as necessary, in accordance with company policies and federal/state regulations, with input from the Human Resources department.
  • Foster a strong sense of communication and collaboration within the organization.
  • Ensure projects are managed in a structured, organized, and cost-efficient manner to meet timelines, budgets, and quality standards.
  • Set appropriate goals and performance standards for the team and provide an atmosphere that fosters innovation and compliance.
  • Participate in decisions regarding internal or external development paths for regulatory filings and approval. Assist in the selection and management of CMO’s and CRO’s.
  • Work collaboratively with the IP team to enhance and expand the company's assets.
  • Foster and maintain compliance expectations with quality, safety, confidentiality, and corporate integrity standards/policies.
  • Develop a budget for the formulation and process development functional areas, manage and allocate resources, and monitor expenditures.
  • Stay abreast of technical knowledge and trends in the controlled-release injectable drug delivery sector.
  • Ensure that all regulatory and internal policies are followed.
  • Perform other related duties as assigned.

  Knowledge, Skills & Abilities

  • Must have experience managing a sizeable research team and working closely with manufacturing and quality functions in a plant environment.
  • Expert knowledge of injectable drug delivery platforms, controlled-release technologies, biodegradable polymers, aseptic processing, 505(b)(2) regulatory pathway, and cGMP regulations highly desirable.
  • Demonstrated scientific project management skills to establish strategic goals and to prioritize, plan, delegate, and evaluate deliverables.
  • Excellent verbal and written communication and presentation skills with the ability to communicate scientific/technical in an easy to understand manner.
  • Strong leadership skills; creating a dynamic environment that fosters transparency, collaboration, and innovative thinking.
  • Superior problem-solving skills; ability to analyze complex sets of data and make sound decisions and recommendations in a timely manner.
  • Strong intellectual capabilities; conceptualizing and developing new and complex injectable technologies.
  • Entrepreneurial mindset; can identify opportunities and execute.
  • Self-motivated and proactive.
  • Excellent coach and mentor; passion for developing high-performing teams.

  Core Values

  • The Vice President Formulation and Process Development is expected to operate within the framework of Tolmar’s Core Values:
  • Consistently operate with the highest standards of ethics and compliance.
  • Take ownership of your actions, successes, and setbacks.
  • Respect each other and understand that honest collaboration is at the heart of our company's success.
  • Go the extra mile to make things happen.
  • Be committed to all we do and the patients we serve.
  • Embrace change with enthusiasm.
  • Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

  Education & Experience

  • Ph.D. in Pharmaceutics, Pharmaceutical Sciences, Biology, Chemistry, Biochemistry, Chemical Engineering, or a related field is preferred.
  • Fifteen plus years of related pharmaceutical or biotech leadership experience.
  • Proven experience in new development in complex injectable products and branded pharmaceutical products.

  Working Conditions

  Working conditions are typical for an office environment.

  Compensation and Benefits

  Annual Pay Range: $285,000 - $325,000
  Bonus Eligible
  Benefits information: https://www.tolmar.com/careers/employee-benefits

  Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.

  Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

  Qualifications

  Education

  Required

  PHD

  Experience

  Required 15 years

  • Fifteen plus years of related pharmaceutical or biotech leadership experience. • Proven experience in new development in complex injectable products and branded pharmaceutical products.

  Behaviors

  Required

  Thought Provoking : Capable of making others think deeply on a subject

  Leader : Inspires teammates to follow them

  Motivations

  Required

  Ability to Make an Impact : Inspired to perform well by the ability to contribute to the success of a project or the organization

  Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

  The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

• About the company

  Tolmar is a pharmaceutical company focused on the development, approval and commercialization of specialty pharmaceutical products in the therapeutic areas of urology and oncology.

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