As a member of the Akorn Quality Analytical Services (QAS) organization, the Senior Analytical Scientist will be responsible for providing direct analytical support to the larger Quality Analytical Services team and Akorn Quality, Technical Service and Operations. The Senior Analytical Scientist will work within a dedicated Quality Analytical Services laboratory. The scope of work will include laboratory testing, product troubleshooting, strategy/test plan development, analytical method validation, and impurity isolation for a broad range of materials and product types. The senior analytical chemist reports to the Supervisor – QAS and will be located on-site within the Amityville NY facility.
- Providing 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 Quality Analytical 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
- Ensure that all data comply with cGMP, FDA and/or other appropriate regulatory guidelines
- Perform other duties as deemed necessary by department management
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.
- 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, KF, IR, UV, DM.
- Good knowledge of organic chemistry is desired.
- 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.
EDUCATION AND EXPERIENCE:
- The individual must also have:
- The ability to comprehend complex instructions and tasks and have strong analytical and logical problem-solving abilities
- Fundamental understanding of algebra and statistics.
- Strong verbal communication and writing skills in English
- 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
Company Overview Who we are?
- Must have a BS in chemistry with 10+ years of experience or Master's or PhD with 5+ years of experience in analytical pharmaceutical industry or related industry.
- 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.
Aside from being a pharmaceutical industry leader with deep roots in the eye care community, Akorn has proven through the years, to be a company of clear vision. A vision of what it takes to continually develop and evolve in order sustain our mission, which is to improve patients' lives through the quality, availability and affordability of our products. Along with developing and manufacturing branded and generic ophthalmics, Akorn manufactures injectable, oral liquid, optic, topical, inhalant, and animal health products. To learn more please visit our website at www.Akorn.com . Why choose us?
Akorn employees are modern day superheroes! That might sound like an exaggeration; however, when you think of it, superheroes help those in need. That is exactly what we do here at Akorn. If you choose to work with us, you are not choosing to work an ordinary job. You are choosing to make an impact in this world. You are choosing to have a career with purpose. If you are seeking a rewarding opportunity where you can make a difference for others, then put on your cape and join the team!!What do we offer?
- Competitive pay
- Growth and development opportunities
- Tuition Reimbursement
- 3 weeks PTO + Personal Days
- 9 company holidays
- 401K match
- Medical, Dental and Vision Benefit Options
- 100% Paid Maternity Leave
- Fast paced, family-oriented work environment
- Wellness Program
- Inclusive and diverse culture
- Adoption Assistance
- Flexible Spending Accounts
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.