Analytical Chemist - Pharma

Location

Brighton, MI | United States

Job description

Are you interested in an exciting and rewarding career within a growing company? Are you motivated to collaborate with a team to achieve goals? Do you have passion for improving the lives of others?

Bryllan is looking for respectful, empathetic, courageous individuals who are eager to utilize their skills in a rewarding career. Bring the knowledge and experience you've gained from your education and career, along with willingness to continuously learn in the pharmaceutical manufacturing industry. If you feel invigorated by the thought of contributing to the creation of life enhancing or lifesaving products, this opportunity could be for you!

Bryllan LLC is a privately owned, rapidly growing Contract Manufacturing Organization (CMO) that has designed a unique sterile filling and containment platform for multi-product filling of cytotoxic, potent, live virus and vaccine, and hormone drug products. We offer a rewarding work environment while maintaining a small company, employee-focused atmosphere. Bryllan differentiates itself from our competitors by living our values of Quality, Integrity, and Service.

The Analytical Chemist conducts responsibilities under the supervision and direction of Analytical Services Management.

The Analytical Chemist is part of the New Product Introduction (NPI) team responsible for onboarding new projects at Bryllan from an analytical perspective. The Analytical Chemist's main responsibility is to support the onboarding of in-process, release, and stability methodologies for chemistry and microbiology assessments. The Analytical Chemist is responsible for development and validation of in-house methods, transferring client methods, and managing third-party outsourced methods that meet all standards required for cGMP regulations. Various techniques are utilized in the shared Quality Control laboratory including HPLC, GC, and multiple types of spectrophotometry.

As an NPI team member, the Analytical Chemist is responsible for attending weekly client calls. The Analytical Chemist is responsible for collaborating with Process Development, Engineering, Project Management, and Quality Assurance to meet client needs.

The Analytical Chemist is a member of the Quality Operations team, responsible for the safe and efficient manufacturing and oversight of drug products.

Essential Duties and Responsibilities:

1. Under the supervision of Analytical Services management, conduct guided development, validation, and transfer of methodologies into the Bryllan Quality Control Laboratory.
2. NPI project delivery; responsible for meeting Bryllan/client project timelines and deliverables.
3. Oversight and coordination of analyses at third-party laboratories.
4. Document laboratory work using laboratory notebooks/worksheets in a detailed and accurate manner that meets cGMP requirements.
5. Investigate and troubleshoot Quality Control methods.
6. Peer review of data, reports, and notebooks to ensure accuracy of raw data and calculations.
7. Perform all work using appropriate safety measures and personal protective equipment.
8. Assist in training others in laboratory procedures.
9. Participate in laboratory investigations.
10. Performance of analytical assays to test the integrity and identity of raw materials, excipients and finished products, as necessary.
11. Assist with maintaining the laboratory consumables inventory and laboratory housekeeping, as necessary.

Specific Position Duties and Responsibilities:

1. Experience with and application of cGMPs, USP/NF, FDA Guidelines and ICH Guidelines
2. Development, troubleshooting, and validation of analytical methods.
3. Installing, qualifying, calibrating, troubleshooting, and maintaining laboratory instruments and equipment
4. Write and execute validation and method transfer protocols, conferring with management and external customers.
5. Write & review Standard Operating Procedures (SOPs) and other controlled documents. Maintain procedures for accuracy and compliance.
6. Provide immediate, effective response to laboratory errors, deviations and investigations.

Behavioral Expectations:

1. Strong work ethic and ability to accomplish tasks without supervision
2. Adhere to and follow all Company Policies and Procedures
3. Excellent interpersonal skills with the ability to cooperate with others in a high-performance setting
4. Basic computer skills (proficient in Microsoft Office applications)
5. Strong mathematical and organizational skills
6. Excellent English communication skills, both written and verbal
7. Must possess honesty, integrity and a commitment to the highest legal and ethical standards
8. Ability to treat every person with courtesy and respect
9. Demonstrate ownership and accountability to production schedule without compromising product quality
10. Knowledge of fundamental cGMP and regulatory principles such as deviations and CAPA

Physical Expectations:

1. Frequent lifting, bending, stooping, squatting, pushing, and pulling.
2. Long periods of sitting and walking.
3. Long periods of sitting, typing, computer entry, or looking at a computer.

Work Experience and Education Requirements:

Minimum of 2 years' experience in the pharmaceutical industry, or equivalent relevant experience.

Minimum of 2 years' experience using HPLC in a laboratory environment, or equivalent relevant experience.

Minimum of 6 months' experience executing supervised method development and validation, or equivalent relevant experience.

Four-year degree in Chemistry, Biology, a related Life Science, or equivalent.

Working knowledge of standard software applications such as Chromatography Data Systems, Microsoft Office, and ERP. Working knowledge of Agilent OpenLab CDS or Agilent ChemStation is a plus.

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