The individual is responsible for performing and leading methods development, chemical and physical assays in support of pharmaceutical development projects. The individual will support the requirements of the stability program, method validation and process development program. The scientist will also perform project management or share with the Product Development Scientist the responsibilities of project management.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide technical support to department where required to ascertain degradation profiles, solve complex scientific problems and develop sophisticated analytical methods. Develop analytical methods for drug substances, preservatives and degradation/impurities in the finished product. Validate new analytical methods in accordance to Akorn, Inc. procedures and FDA regulations. Maintain Lab equipment and keep all the records up-to date.
- Provide technical leadership for the analytical development. Assist R&D Supervisor in the laboratory management. Develop and validate stability indicating assay procedures for pharmaceutical chemicals and finished dosage forms.
- Perform testing of samples as required to support product development, regulatory submissions and the commercial stability program. Perform laboratory work to support product or process troubleshooting, special investigations and product complaints with sufficient supervision. Assist in the general operation of the Research & Development analytical laboratory, including maintenance of Standard Operating Procedures (SOPâ€™s), training and equipment validation or maintenance.
- Perform laboratory work to support method validation or investigations. Assist performing validation of new equipment and the maintenance of the existing analytical equipment. The individual will participate in the writing of stability reports, product development reports and product specifications. Maintain accurate and complete laboratory records as required by company policy and Good Manufacturing Practices (cGMP) requirements.
- Assist formulation or other analytical scientists in the testing or preparation of drug products and samples. Set and accomplish product development timelines working closely with formulation scientist. Perform other duties as deemed necessary by the department management.
- Design, develop, conduct and provide preliminary interpretation of study results with high level of independence.
- Develops and validate analytical methods for drug substance, excipients, drug products, related substances, preservatives etc.
- Executing analytical experiments, training analytical chemists to develop and validate analytical methods for new products.
- Managing projects by establishing schedules, project plans and direct activities for other chemist and providing training and development for others.
- Improving old in-house procedures or compendial methods using newer techniques to achieve better consistency, time and cost effectiveness.
- Analysis of finished product, stability and in process sample.
- Identifies specification requirements for drug substance, excipients, and drug products.
- Responsible for transferring of analytical procedure by proactively communicating with the other labs and ensuring testing is completed in a timely manner.
- Authoring and reviewing technical reports, methods, validation protocols and SOPs for routine analysis as well as the reports to support ANDA submissions.
- Provide analytical test results to support formulation development, including compositional analysis of innovator formulations to support generic product development.
- Working with wet chemical techniques and instrumental analysis, such as Karl Fisher, Moisture analysis, UV.
- Coordinating with other members of various groups including Formulation Development, Quality Control, Production, Regulatory Affairs, Quality Assurance and Purchasing in order to expedite the development and validation of analytical methods for new products.
- Identifies new analytical tools and methods and introduces them into practice.
- Assist in performing cGMP audits periodically in R&D to ensure the development activities and documentation practices are as per regulations.
- Bachelors degree in chemistry, bio-chemistry or Life Science and will have 9+years experience or masters degree with 7+years experience or a Ph.D. with 6+years experience in analytical methods development and validation.
- Experience with FDA and cGMP regulations and guidelines.
- Proficiency with modern methods of pharmaceutical analysis- including HPLC, GC, titrimetric methods, Ion Chromatography and Mass Spectrometry, compendial wet chemistry techniques, and statistical analysis.
- Sufficient experience in product development to define analytical objectives and resource requirements for a product development project
- Experience working with Regulatory and/or Formulation groups in a project team.
- Proficiency in documentation must be demonstrated,
- Understanding of cGMP compliance requirements is essential.
- Experience with analytical method development and reverse engineering for suspension and emulsion products
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.EEO Statement
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
This job has expired.