This position will be responsibility for planning and coordination of the Analytical R&D and Quality Control functions and will oversee all analytical development, testing and reporting by our third-party partners from pre-IND stage to marketed product approvals. This position will provide the technical expertise required to manage analytical product development and contract testing activities for the Company's pharmaceutical products. This position will also include responsibilities for the development and implementation of CMC development strategies and managing third-party labs across clinical and commercial projects.
Essential Job Function:
Establish robust analytical CMC development strategies, plans, timelines and budgets and track status, progression, critical success factors and risk factors in the ongoing and planned CMC development projects including:
Method development and validation for control of raw materials, drug substance, drug product intermediates, and finished drug products
Development testing, analysis and technical support
Specification development for raw materials, drug substance, drug product intermediates, and finished drug products
Raw material evaluation, testing, release and vendor qualification
Clinical trial material evaluation and release testing
Stability study design, execution, monitoring, reporting, and data trending and analysis
Method transfer to contract manufacturing organizations
Provides leadership for investigations at contractor sites. Leads implementation of corrective actions and quality system improvements
Responsible for Quality Control function for commercial products manufactured at third party manufacturing organization:
Batch data review and trending
Annual product review preparation and review
Annual report preparation and review
Design and implementation of stability commitments
Supports in technical audits of external manufacturing partners to ensure compliance with regulatory requirements and regulations
Partners with Quality Assurance to ensure that SOP's are in place and followed.
Provide training and guidance to partners (internal and external) on analytical research and development best practices
Responsible for development and implementation of analytical function:
Provides strategic input into department structure, policies and procedures
Provides direction and leadership to internal and vendor staff
Develops staff through mentoring, training, coaching and feedback
Plans and directs work activities, establishes realistic goals and objectives, and monitors progress toward those goals so timelines can be met and be achieved
Ensures decisions are scientifically-sound and supported by data.
Prepares and reviews analytical sections of CMC regulatory filings for both FDA and international filings
Supports due diligence of CMC for in- and out-licensing activities.
Provides recommendations and input on departmental policies, new product opportunities, product developmental strategies, procedures, resourcing, budgets, goals and objectives.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice."
A Ph.D. or Master's degree in the life sciences, preferably chemistry or pharmaceutical sciences.
15+ years (or equivalent) in an analytical development and control function with increasing levels of responsibility
Expertise in complex investigations, method development, validation and transfer and/or regulatory registration of drug products
Comprehensive understanding of regulatory requirements for the drug development process and manufacturing
Writing and maintenance of regulatory filings (IND, NDA,MAA)
Significant experience operating in a virtual business model
A minimum of 12 years previous management experience and building and managing analytical functions in commercial and development organizations
Excellent communication and project management skills are required as this position is responsible for the scientific evaluation and coordination of work performed by external partners
Strong leadership, interpersonal, oral and written communication and team building skills
This position primarily works in an office environment. It requires the ability to sit or stand for long periods of time and frequent walking. Daily use of a computer, phone, office equipment and other computing and digital devices is required. May be required to stand for extended periods when facilitating meetings or walking in the facilities. Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver's license and/or effectively navigate public transportation is required. While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings. The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel. The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear. Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies. The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden. While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles. May be subject to smells and odors. The noise level in the work environment is usually quiet to moderate. The passage of employees through the work area is average and normal.
As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law. All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination. Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.
Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a). These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.
Avanir Pharmaceuticals, Inc