Job Description

Description :
Purpose and Scope
Oversees the analytical development of Tolmar's overall portfolio of products and technologies. Pursues and manages all analytical CMC activities needed to support the design of new products that span multiple therapeutic areas through research, development, and clinical studies to bring a product to market in compliance with global regulatory, scientific, and legislative standards and requirements. This position functions as the scientific liaison to business partners and thought leaders in areas of interest to the company.
Essential Duties & Responsibilities

• Evaluate and monitor the department's objectives and operations to ensure alignment with overall company objectives.
• Serve as a strategic scientific leader in evolving the company's research and development programs, including generics, proprietary, and long-acting injectable portfolio, including drug-device combination products.
• Set near-term and long-term strategic directions of the department aligned with R&D objectives and deliverables, to ensure delivery of the company's product pipeline.
• Manage all lab activities related to the development and optimization of robust analytical methods aimed at quantification of raw materials, APIs, intermediates, and finished products for timely clinical supplies.
• Work with both internal and external stakeholders to develop phase-appropriate analytical strategies to support the seamless progression and transition of projects from candidate selection through product licensure and launch.
• Provide technical leadership and guidance for troubleshooting and problem-solving activities related to processes and laboratory investigations.
• Collaborate with Product Development, MS&T, Manufacturing, Marketing, and Quality Assurance departments to coordinate production and release of new products.
• Act as liaison between department management and subordinate levels, as well as executive and department-manager levels, to inform personnel of communications, decisions, policies, and all matters that affect their performance, morale, and results.
• Implement appropriate SOPs and ensure SOP and GLP compliance.
• Assure appropriate communications of project status and issues.
• Manage sustainable talent development to recruit, develop, and retain top talent in all functional areas to deliver project objectives.
• Lead/participate in senior cross-functional matrix CMC steering teams to provide technical guidance for all analytical related activities.
• Participate in due diligence activities to provide critical analytical assessment in business development efforts.
• Oversee regulatory submissions and communications related to analytics and supporting regulatory filings.
• Cultivate a team culture that respects Tolmar's core values and innovation and promotes teamwork and collaboration.
• Foster and maintain expectations of compliance with quality, safety, confidentiality and corporate integrity standards / policies.
• Develop a budget for functional areas, manage and allocate resources, and monitor expenditures.
• Write and/or review technical documents (internal reports, external disclosures, regulatory documents, etc.).
• Establish and leverage strategic relationships with CRO's and academia to access emerging innovations.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities

• Demonstrated understanding of analytical development and be able to think critically and strategically about how analytics relate to CMC development path and product life cycle management.
• A demonstrated ability to establish a root cause. A candidate must display a working aptitude to systematically analyze a problem to find its fundamental source rather than addressing symptoms.

• Broad-based technical expertise necessary to lead the development of generic and proprietary pharmaceutical products.
• Prior leadership role in analytical development specializing in specialty injectables, long-acting injectable products involving polymer, small molecules, and protein/peptides.
• Entrepreneurial mindset with the ability to take intelligent risks, competence in analysis, solving problems, and prioritizing and making difficult trade-off decisions to achieve overall business objectives.
• Strong data analysis, interpretation, and documentation skills. Specific experience in Chromeleon software would be desirable.
• Expert knowledge of FDA, International, and cGMP regulations & guidelines.
• Excellent planning skills, including resource allocation and timeline development.
• Skill in effective oral and written communication.
• Proven interpersonal and leadership skills.
• Ability to interact and influence successfully across boundaries with cross-functional areas and disciplines.
• Ability to manage, direct, lead, and coordinate others.
• Expert knowledge of Electronic Lab Data systems, advanced statistical analysis, and implications to 21 CFR part 11 and global regulations.

Core Values
This position is expected to operate within the framework of Tolmar's Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.?
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.?
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• ?Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.?
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.?

Education & Experience

• Master's or Ph.D. in Pharmaceutical Chemistry, Chemistry, Biochemistry, Chemical Engineering or related field with demonstrated ability to lead successful programs.
• Fifteen plus years of related pharmaceutical or biotech research and development experience required.
• Ten years of demonstrated leadership of large teams (20+ FTEs) with the ability to drive a positive environment and culture that fosters ownership, accountability, empowerment, and the development of team members, which will enable the progression of their scientific and managerial career paths.
• Demonstrated experience utilizing a Quality by Design approach in product development.

Working Conditions

• Working conditions are typical for an office environment.
• Some travel may be required.

Compensation and Benefits

• Annual Pay Range: $300,000.00 - $325,000.00
• Bonus eligible
• Benefits information:
• 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 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.
Skills : Knowledge of Management Principles: Required Expert
Knowledge of the Pharmaceutical Industry: Expert
Behaviors : Leader: Inspires teammates to follow them
Motivation : Ability to Make an Impact: Inspired to perform well by the ability to contribute to the success of a project or the organization
Education : PHD
Experience : 15 years: o Fifteen plus years of related pharmaceutical or biotech research and development experience required. o Ten years of demonstrated leadership of large teams (20+ FTEs) with the ability to drive a positive environment and culture that fosters ownership, accountability, empowerment, and the development of team members, which will enable the progression of their scientific and managerial career paths.

Skills Required