Manager, Analytical Development

Purpose and Scope

Manages the development of appropriate assays for testing and release of pharmaceutical products, raw materials, and stability samples.  Provide management oversight and leadership to the Analytical Development laboratory staff.

Essential Duties & Responsibilities

• Manage the development and validation of methods for stability testing and release of pharmaceutical products and raw materials.
• Facilitate successful method transfer.
• Manage the development of methods to support one or more projects at different phases of maturity.
• Evaluate analytical data for validity.
• Ensure operation and function compliance with FDA, GMP and/or GLP guidance, as appropriate.
• Writes, reviews and/or approves technical reports, analyses, test methods against current guidelines and/or specifications.
• Participate in audits (as needed) and directly interacts with potential marketing partners and regulatory agencies. 
• Provide a leadership role for Analytical Development.
• Initiate and conduct laboratory investigations.
• Guide the creation of regulatory documents for FDA submissions.
• Prioritize projects to meet timelines and prepare/oversee work schedules to ensure on-time delivery of results within the analytical development group.
• Generate, review, and approve certificate of analysis, certificates of testing, and stability reports when needed.
• Manage testing of pharmaceutical products, raw materials, stability samples.
• Hire, train, manage, counsel and evaluate direct-report employees; conduct and submit annual performance appraisals; recommend pay adjustments as appropriate.
• Set procedure and ensure compliance from Analytical Development staff.
• Independent management of projects and personnel.
• Participate in project team meetings to aid in product development using expertise to facilitate analytical development of viable products to meet project goals.
• Manage and approve departmental spending to stay within budget.
• Foster discussion of continuous improvement throughout department operations.
• Ability to conceptualize, create, and manage in-house and CRO analytical methods to drive IND and NDA submissions to the FDA.
• Participates in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes, and transfer of hazardous waste between lab procedure area, satellite accumulation, and storage. Responsible for daily activities and supervising staff that are hazardous waste generators and/or handlers. Respond to spills according to the Chemical Spill Response procedure.
• Perform other related duties as assigned.

Knowledge, Skills & Abilities 

Knowledge

• Thorough proficiency of government regulations of drugs and medical devices as they apply to laboratory work. 
• Expertise in current Good Manufacturing Practices (cGMP), FDA and International regulations as they apply to laboratory work.
• Expertise in investigations
• Expertise in analytical method development and validation.
• Demonstrated proficiency of computer systems for sample tracking, laboratory equipment, raw data handling and storage. 
• Strong proficiency of general accounting procedures.

Skills

• Excellent interpersonal, communication, problem-solving and organizational skills.
• Excellent skill in effective oral and written communication.
• Strong technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Supervisory experience with exceptional interpersonal and organizational skills that lead directly to the advancement of others and of the department as a whole.

Abilities

• Manage a team of analytical professionals that is fully compliant with current Good Laboratory Practices and Good Manufacturing Practices.
• Oversee and prepare, review, conduct, develop and/or validate analytical methods and product specifications.
• Efficient in troubleshooting product and project issues.
• Coordinate and manage activities to assure customer needs and project goals are met.

Core Values

• The Manager Analytical 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, 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

• Bachelor’s degree in chemistry or a related discipline.
• Eight or more years of related industry experience with a minimum of two years supervisory experience.

 Working Conditions

• Laboratory setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.

Compensation and Benefits

• Salary Range $115,000 - $125,000
• Bonus Eligible
• Benefits - https://www.tolmar.com/careers/employee-benefits 

Salary : $115,000 - $125,000