We seek 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.
Independently develop analytical methods for drug substances, drug product, preservatives and degradation/impurities in the new drug products.
Perform validation experiments as per approved method validation protocols, Company SOP and ICH guidelines.
Perform in-process, finished product/release and stability testing of dosage forms as per the approved methods.
Perform Extractable/leachable studies for container closure systems of drug products
Provide analytical support to formulation group in order to finalize the formulation composition and components 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/ANDA submissions.
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, USPmethodologies, cGLPs and 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 and equipment validation or maintenance.
Additional responsibilities can also be assigned to support business needs.
Qualifications ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES 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-vitro characterization techniques. Experience with analytical method development and reverse engineering for suspension and emulsion products desired.
EDUCATION AND EXPERIENCE: The successful candidate will hold a degree in Chemical or Life Sciences from an accredited university and will have one to four years' experience in analytical methods development in a small molecule product environment. A recent PhD with small molecule experience will be considered.
Company Overview 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.