As a member of the Akorn Quality Analytical Services organization, the Senior Analytical Chemist will be responsible for providing direct analytical leadership to Akorn operations and Quality. The Senior Analytical Chemist will work within a dedicated QAS Laboratory. This is a laboratory position and requires liaising within numerous departments and staff. The scope of work will include: direct laboratory testing, product troubleshooting, strategy/test plan development, analytical method remediation activities, and impurity isolation/identification for a broad range of materials and product types.The Senior Analytical Chemist reports to the Supervisor â€" QAS and will be located on-site within the Amityville NY facility.
Include the following. Other duties may be assigned.
- Provide analytical chemical testing/laboratory work in support of the QAS department, Operations and Quality where required for commercial product support including but not limited to method development, method validation, product testing, degradation profiles, impurity identification, extractable leachable testing, and material contact studies. Material scope includes but is not limited to API, in process testing and finished drug products of the product forms noted in the company summary
- In coordination with other QAS personnel design investigation schemes to support commercial product troubleshooting and execute designed lab experiments
- Troubleshoot and remediate analytical test methods for a wide range of API, excipients and finished products
- Design and execute test method development
- In association with maintenance and analytical vendors as needed install, qualify and maintain the required laboratory equipment within the Technical Services laboratory
- Perform the analytical laboratory work to serve as the sending lab for test method transfer as needed within Akorn sites, contract manufacturing facilities and contract laboratories
- Document and maintain data/test results according to GMP. Produce reports and present results as required for management updates
- Operate and maintain the QAS Laboratory within GMP and SOP requirements and within budget
- Perform other duties as deemed necessary by department management
- Ensure that all data comply with cGMP, FDA and/or other appropriate regulatory guidelines
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION AND EXPERIENCE:
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily, including many hours of laboratory work on a routine basis. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The individual must have demonstrated thorough working knowledge of chemical analysis for raw materials and finished products, including HPLC, GC, IR, UV.
- Good knowledge of organic chemistry is desired
- The individual must also have:
- knowledge of regulatory requirements for the pharmaceutical industry as they pertain to analytical technology, including knowledge of ICH guidelines, FDA requirements, and USP procedures and monographs.
- fundamental understanding of algebra and statistics
- strong verbal communication and writing skills in English
- the ability to comprehend complex instructions and tasks and have strong analytical and logical problem solving abilities
- strong project management skills
- ability to excel in a cross-functional working environment and the ability to multi-task, prioritize and handle multiple projects at once
- ability to collaborate with other teams, as well as maintain and strengthen cross departmental relationships
- Minimum of PhDin Chemistry with 5+ years of experience in the analytical units within the pharmaceutical or related industrial experience.
- Strong project management and organizational skills, prioritizes and plans work activities; uses time efficiently; plans for additional resources; sets goals and objectives; organizes or schedules efficiently; and develops realistic plans
- Follows instructions, responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan
- Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure high quality
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.