We are seeking talented Analytical Scientists at various levels to join our expanding R&D team. You will be responsible for methods and process development for ANDA topical, suspensions and solutions, nasal sprays, inhalations, sterile injectable and ophthalmic products. You will develop and validate new analytical methods, conduct stability studies and perform sample testing to support regulatory submissions.
Position can be based in Illinois or New Jersey.
Duties & Responsibilities:
- Independently develop analytical methods for drug substances, drug product, preservatives anddegradation/impurities in the new drug products.
- Perform validation experiments as per approved method validation protocols, Company SOP and ICHguidelines.
- Perform in-process, finished product/release and stability testing of dosage forms as per the approvedmethods.
- Perform Extractable/leachable studies for container closure systems of drug products
- Provide analytical support to formulation group in order to finalize the formulation composition andcomponents for new products.
- Perform analytical method transfer from R&D to QC laboratory for newly validated methods
- Write/revise analytical methods, method validation protocols, method development and validation reports,method transfer protocols/reports, In-vitro comparison reports etc.
- Perform Out of Specification (OOS) and Out of Trend (OOT) investigations.
- Responsible for Chemistry, Manufacturing and Controls (CMC) documentation required for NDA/ANDAsubmissions.
- Provide technical support to QC in trouble-shooting on existing analytical methods.
- Perform Identification studies for unknowns in drug products using Raman, LC/MS, GC/MS, Raman etc.
- Perform calibration of analytical equipment as per approved procedures.
- Execute all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGLPsand Company SOPs.
- Document all activities in the appropriate laboratory notebook as per SOPs and cGLPs.
- Assist in the general operation of the Analytical R&D laboratory, including maintenance of SOP's, training andequipment validation or maintenance.
- Additional responsibilities can also be assigned to support business needs.
- The successful candidate will hold a degree in Chemical or Life Sciences from an accredited university and wilhave one to seven years' experience in analytical methods development in a small molecule productenvironment. A recent PhD with small molecule experience will be considered.
- Must be knowledgeable or have hands on experience in a broad range of instrumentation including UPLC,HPLC, LCMS, GC, GCMS, Dissolution, Diffusion, Particle size, Raman, ICP-MS, IR, UV and Nasal In-vitrocharacterization techniques.
- Experience with analytical method development and reverse engineering for suspension and emulsionproducts desired.
- Incumbent will be hired at a level based on years of relevant experience.
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.
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.