Job Description

Job Description

Job Description

Job Summary:

• Join our Parenteral Product Development Science and Technology - Analytical Development group and contribute to exciting programs transitioning from the development stage to optimization and commercialization.

• As a member of the team, you will support the development, optimization, and validation of analytical methods by ensuring that they are well documented.

• You'll gain experience in documentation of product control strategies, analytical methods, and stability studies.

• Support Analytical Leads and Lab Managers by assisting with the creation and review of protocols, reports, specifications, and other technical documents. This may include facilitating communication between different laboratories, reviewing data, drafting sections and data tables, data verification, and other tasks

• Execute change management processes for document updates.

• Assist in compiling and verifying information for submissions and responding to health authority queries.

• Gain hands-on experience in regulatory compliance and analytical data.

Qualifications :

• Bachelor's Degree in a scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) and 5+ years' experience

• Master's or PhD with 2+ years' experience.

• Needs to have GMP documentation skills

• Basic understanding of analytical methods, test method validation, and Good Documentation Practices.

• Good organizational skills and attention to detail.

• Ability to manage and prioritize multiple projects simultaneously and to work within timelines.

• Interest in learning and developing scientific writing skills.

• Interest in learning about international pharmaceutical guidelines and regulatory submission processes.

• Practical experience in method validation of analytical or bioanalytical techniques (for example: HPLC, SEC, CEX, icIEF, CE-SDS, ELISA, etc.) is a plus.

• Experience Level = 3-5

Benefits:

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.

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