We seek self-motivated, talented Formulation Scientists at various levels to join our expanding R&D team who will be responsible for developing the final product formulation, process procedures and packaging of semisolids, suspensions and solutions, lotions, nasal sprays, inhalations, sterile injectable and ophthalmic products etc.
Key Responsibilities Include But Are Not Limited To
- Literature searching and review, patent searching and interpretation, performing risk assessment for formulation/process development, conducting experimental design and execution of lab scale and pilot scale engineering batches to support the final formulation and processes leading to exhibit batch manufacturing.
- Evaluation and selection of active, inactive raw materials and packaging components for various products.
- Design, and manufacture laboratory test batches according to self-written instructions to support product development, regulatory submissions and analytical method validation program.
- Development of CPPs, QTTPs, CQAs, and scale up manufacturing processes.
- Preparation of various study protocols to conduct compatibility studies including product contact studies with manufacturing train materials equipment and container closure system(s).
- Perform technology transfer of developed processes and procedures to scale-up activities.
Participate in activities leading to Technical Transfer, process performance qualification and commercial production troubleshooting.
- Clearly document all data generated and report all research work performed - includes creation and documentation of study and experimental protocol, development of experimental process, identification and corrections of developmental and manufacturing issues/problems/ observations and writing product development report (PDR) based on Quality by Design (QbD) guidelines.
- Prepare GMP documents for Exhibit Batches including technology transfer report.
- Prepare and update daily, monthly report and Drug Development Plan on experimental activities and results.
- Familiarity with interpretation of data generated by various developmental analytical tools including HPLC, GC, particle size analyzer, DSC, XRD, Raman, Spectroscopic, etc.
- Assist in the general operation of the R & D formulation laboratory, including maintenance of SOPâ€™s, training and equipment validation or maintenance.
- Additional responsibilities can also be assigned to support business needs.
EDUCATION AND EXPERIENCE:
- Generic R&D experience and successful track record of ANDA submissions is a plus.
- Hands-on experience in formulation development of the mentioned dosage forms is essential.
- A sound knowledge of processing equipment for sterile and non-sterile product manufacturing is essential.
- A thorough knowledge of regulatory requirements for product development and cGMP are mandatory.
- Experience with laboratory equipment like particle size analyzer, rheometer, viscometer, homogenizer/high shear mixture, sterilization and nasal in-vitro characterization techniques is a plus.
- The successful candidate must have excellent communication skills (verbal and technical), leadership and peopleâ€™s skills, demonstrate the ability to plan, design, implement and analyze laboratory experimentation to advance projects and guide the formulation and process development, leading to commercial formulations and manufacturing processes.
Minimum Bachelorâ€™s degree in Pharmaceutical Sciences or related field from an accredited university with at least one year related experience and/or training; or equivalent combination of education and experience. Demonstrated abilities in at least one or more the mentioned areas of formulation development for stable bioequivalent generic product by QbD approach and technology transfer for manufacturing process from laboratory scale to production scale. Company Overview Who we are?
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 patientsâ€™ 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.comWhy 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.
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