Include the following. Other duties may be assigned.
- Ordering of reference products, raw materials and packaging components required for the development of stable formulations.
- Design experiments to develop a Robust formulation and manufacturing procedures for Sterile and Non-Sterile Liquid/Semisolid formulation with QbD approach.
- Physico-Chemical characterization of the reference products and developed formulations.
- Formulate laboratory test batches to support product development, regulatory submissions and the method validation program.
- Independently manage product development requirements independently to meet the set project timeline.
- Coordinate and track tasks involving analytical development, production, and regulatory affairs.
- Develop protocols and procedures for product Scale up/Engineering batch, process verification and Exhibit Batches.
- The Scientist is also responsible for documentation of the product development history and final product specifications along with Analytical Development Scientist.
- Perform laboratory work to support product or process troubleshooting, special investigations and product complaints.
- Assist in the general operation of the R & D formulation laboratory, including maintenance of SOP’s, training.
- Support equipment purchase, validation and maintenance.
- Maintain accurate and complete laboratory records as required by company policies and SOPs. Adherence and compliance to cGMP’s, GLPs and Data integrity is a must.
- Assist other Formulation or Analytical Scientists in the development or preparation of drug products and samples.
- Support and train Junior Scientists as deemed necessary.
- Conduct peer review of laboratory notebooks and batch records.
Company Overview Who we are?
- Bachelor of Science Degree (B. S.) in the life sciences or Chemistry fields from a four-year college or university with a minimum of 6 years related experience OR
- Master's degree with 4 years of related experience OR
- Ph.D. with 3 years related experience.
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.
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