Manager Early Stage Development

Purpose and Scope

Provide management oversight and leadership to the Early-Stage Product Development staff for early evaluation and prototyping of pharmaceutical products while ensuring compliance with all Tolmar's cGMP, SOP's and FDA regulations. Develops and drives the team to ensure product development timelines are met.

Essential Duties & Responsibilities

• Oversee the early-stage development of new product strategies and prototypes which meet the clinical and commercial requirements for the finished product.
• Define plans and timelines for robust early evaluation of product concepts that lead to product transitions to full development.
• Oversee the development of new delivery technologies and incorporate existing or emerging technologies to develop specialty injectable products.
• Lead development efforts of complex products and proprietary formulations.
• Collaborate with functional areas including formulation, analytical, polymer, device, manufacturing, regulatory, clinical, commercial, medical and project management staff to ensure the successful transfer of processes and information with flawless execution to meet project deliverables and milestones.
• Carry out management responsibilities in accordance with company policy and applicable laws including but not limited to interviewing and evaluating candidates for positions, assigning work and providing coaching and training to staff and appraising performance.
• Identify training needs within the department and ensure training requirements are met.
• Work closely with patent attorneys to establish and protect intellectual property.
• Write/review technical documents supporting INDs/NDAs that also may include papers for publications regarding new or emerging topical delivery systems.
• Perform various other duties as assigned.

Knowledge, Skills & Abilities

• Mastery of formulation and/or analytical development skills covering multiple dosage forms, having demonstrated success with other emerging technologies, proprietary formulations, and analytical approaches relevant to overall product development.
• Solid knowledge of drug delivery methods, including injectable, medical device and controlled release technologies.
• Demonstrated solid leadership when working on complex problems within early product development and tech transfers in which analysis of situations or data requires an in-depth evaluation of various factors.
• Proficient in the interpretation of and contribution to patent applications.
• Proven skill in effective management and leadership. Supervisory experience with exceptional interpersonal and organizational skills that directly relate to the advancement of others and the department.
• Excellent oral and written communication skills demonstrated through interactions internally and externally with marketing partners, vendors, and legal counsel.
• Ability to manage multiple projects.

Core Values

• The Early-stage Development Manager 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, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company 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

• BS, in Chemistry, Biochemistry or Pharmaceutical Sciences required. PhD preferred.
• Pharmaceutical experience related to supervisory/development of multiple dosage forms combined with Bachelor's degree 10+ years; Master's 8+ years; PhD 6+ years minimum of one year supervisory experience.

Working Conditions

• Laboratory setting. Will be exposed to solvents, biohazardous materials and pharmaceuticals.

Compensation and Benefits

• Pay range: $130,000 - $140,000
• Bonus Eligible
• Benefits summary: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.

Working Conditions

• Working conditions are normal for an office environment.

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.

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)