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Careers | Available Positions
Available Positions:
If you are interested in employment opportunities at ANI Pharmaceuticals, e-mail your resume to hr@anipharmaceuticals.com. All resumes are carefully reviewed to determine whether candidates meet the
needs of open positions. Resumes that do not meet our immediate hiring needs are kept on file for three months and regularly reviewed for potential
matches. Due to the number of resumes received, we cannot reply to all submissions.
ANI Pharmaceuticals provides equal employment opportunities to all persons without regard to race, sex, national origin, religion, age, disability or
veteran status. We encourage diversity within each department and the Company as a whole. Equal Employment Opportunity guidelines are used every
time we interact with our applicants and employees and include, but are not limited to recruiting, hiring, promotion, transfer, training, discipline
and termination.
Director, Regulatory Affairs
The Regulatory Affairs Manager will develop strategies for the filing of ANDA products and maintain compliance with currently approved NDA and ANDA products.
Position Responsibilities: - Maintain up to date knowledge on current US Regulatory requirements and ICH guidelines.
- Function as the liaison between the Company and US Regulatory Agencies
- Participate as a team member on Product Development Teams
- Preparation of high quality submissions of ANDA’s, Annual Reports, and Supplements/Amendments.
- Perform internal evaluation of change controls and assess the impact on Regulatory filings and develop filing strategies.
- Facilitate timely Regulatory Approvals by ensuring the Quality and appropriateness of submission documents.
- Maintaining Regulatory compliance of marketed products.
- Performs other duties as assigned or requested.
Position Requirements: Minimum Education:
• BS/MS/Pharm.D or Ph.D. in Chemistry, Biology, Biochemistry, Engineering or related Pharmaceutical field or equivalent experience.
Minimum Experience:
• A minimum of 10 years of direct experience in filing ANDA’s, Annual Reports and Submissions/Amendments.
Minimum Field of Expertise:
• Must posses eCTD advanced publishing skills
• Ability to work independently, take initiative and complete tasks to meet deadlines.
• Strong attention to detail, establishing priorities, scheduling and meeting deadlines.
• Must be able to effectively manage multiple projects with competing priorities
• Ability to work effectively with cross-functional teams and to influence appropriate plans and actions.
Supervised: Level
• Supervises Employees who do not supervise
Travel:
• 5-10% Travel
Working Conditions:
• Office Environment
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Formulation Scientist/Sr. Formulation Scientist
This position is responsible for development of pharmaceutical dosage forms, specifically for immediate release and extended release solid dose products, and to prepare products for subsequent scale-up in a multi-disciplinary team setting. Plan, define and over see long-term and short-term goals for Product Development in support of commercial manufacturing. Participate as a member of the in house and contract Product development teams through the Product Development process. Successfully transfer products and technology from in house and external development partners to ANI facilities.
Position Responsibilities:
This position will work closely with the Analytical Development team to develop products for ANDA Submissions. Design and develop a formulation strategy to expedite product development for oral dosage forms. Evaluate patents and work around the exclusivity to generate high-barrier applications in the generic market. Assist in establishing meaningful specifications for raw materials and finished products in cooperation with Quality Assurance and Regulatory Affairs. Resolve pharmaceutical processing problems. Troubleshoot manufacturing process optimization problems encountered during scale-up and transfer of drug products. Assist with Regulatory Affairs on document preparation and pharmaceutics consulting when required Work with the Product Development Team to design the drug development report to be included in the ANDA submissions.
Position Requirements:
Formulation Scientist
PhD with 0-2 years relevant experience
MS with 2-4 years relevant experience
BS with 5-7 years relevant experience
Sr. Formulation Scientist
PhD with 2-3 years relevant experience
MS with 4-6 years relevant experience
BS with 7-10 years relevant experience
The ideal candidate posses comprehensive technical knowledge of pharmaceutical formulation development and manufacturing operations and has extensive hands on experience in solid dose formulation. A Working knowledge of pharmaceutical process validation principles and its application. Previous pharmaceutical industry experience and thorough knowledge, interpretation and communication of GMP’s.
Requirements also include:
- Experience with immediate and extended solid dose products
- Experience in assisting in the preparation of ANDA’s.
- Ability to assign and monitor the work of other team members as well as work in a team environment
- Ability to manage multiple projects within a fast paced environment
- Attention to detail
- Excellent organizational and follow through skills
- Excellent technical writing skills
- Excellent written, verbal communication and PC skills
- Ability to draw appropriate conclusions and make technical recommendations
Apply Now! | Top
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