The individual is responsible for performing and leading methods development, chemical and physical assays in support of pharmaceutical development projects. The individual will support the requirements of the stability program, method validation and process development program. The scientist will also perform project management or share with the Product Development Scientist the responsibilities of project management.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Include the following. Other duties may be assigned.
- Develop analytical methods for drug substances, preservatives and degradation/impurities in the finished product. Validate new analytical methods in accordance to Akorn, Inc. procedures and FDA regulations. Maintain Lab equipment and keep all the records up-to date.
- Develop and validate stability indicating assay procedures for pharmaceutical chemicals and finished dosage forms independently or closely working with the principal scientist as necessary.
- Perform testing of samples as required to support product development, regulatory submissions and the l stability program. Perform laboratory work to support product or process troubleshooting, special investigations and product complaints with sufficient supervision. Assist in the general operation of the Research & Development analytical laboratory, including maintenance of Standard Operating Procedures (SOPâ€™s), training and equipment validation or maintenance.
- Perform laboratory work to support method validation or investigations. Assist performing validation of new equipment and the maintenance of the existing analytical equipment. The individual will participate in the writing of stability reports, product development reports and product specifications. Maintain accurate and complete laboratory records as required by company policy and Good Manufacturing Practices (cGMP) requirements and Good Document Practices (cGDP).
- Assist formulation or other analytical scientists in the testing or preparation of drug products and samples. Set and accomplish product development timelines working closely with formulation scientist. Perform other duties as deemed necessary by the department management.
- Design, develop, conduct and provide preliminary interpretation of study results with high level of independence.
Company Overview Who we are?
- Bachelors degree in chemistry, bio-chemistry or Life Science and will have 6+years experience or masters degree with 4+years experience or a Ph.D. with 3+years experience in analytical methods development and validation.
- Experience with FDA and cGMP regulations and guidelines.
- Proficiency with modern methods of pharmaceutical analysis- including HPLC, GC, titrimetric methods, Ion Chromatography and Mass Spectrometry, compendial wet chemistry techniques, and statistical analysis.
- Sufficient experience in product development to define analytical objectives and resource requirements for a product development project
- Experience working with Regulatory and/or Formulation groups in a project team.
- Proficiency in documentation must be demonstrated,
- Understanding of cGMP compliance requirements is essential.
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 atwww.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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