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Microbiologist II

Billerica, Massachusetts

Category Quality Job ID R-46949

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Sun Pharma is the world’s fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.

Job Summary:

Perform GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology.

Areas of Responsibility:

Record GMP data, monitors and evaluates QC systems and equipment

Implement improvements to procedures, and revises SOP’s and GMP documentation as required

Interact with internal and external auditors including government agencies and contract manufacturing representatives

Perform sterility and endotoxin testing for release, stability, and validation for raw materials, in-process and final products

Maintain Sterility and Endotoxin testing areas in a state of cGMP compliance

Perform and review growth promotion testing data for qualification of microbial culture media

Perform microbial identification related to product and environmental testing

Perform sampling of raw materials as required for QC testing

Perform routine quality control testing as required and monitors or evaluates systems, equipment (i.e. water systems, environmental chambers, sample collection and testing instruments/equipment)

Maintain records in paper based or computer based systems

Author and execute method validation/suitability protocols related to product testing

Author summary reports for executed method validation/suitability protocols

Author deviation reports and microbiological assessment reports related to departmental activities and product testing

Review Microbiology testing data as required

Coordinate receipt of raw material, in-process and final product samples for testing

Maintain metrics for receipt and processing of samples for microbiology testing

Provide technical input on product testing issues and instrumentation/equipment

Serve as liaison to service, calibration and technical representatives

Conduct and document assay failure and complaint investigations

Perform other duties as assigned

Job Qualifications and Experience:

2-4 years related experience in a Pharmaceutical/drug (FDA Regulated) industry preferred
BS in Microbiology or related field or equivalent industry experience is required

Experience in pharmaceutical microbiology and microbiology testing not limited to endotoxin, method validation, sterility, bioburden, microbial identification, growth promotion and environmental monitoring testing; ability to perform standard and non-standard microbiology techniques to analyze product

Excellent verbal, written and interpersonal communication skills

Proficient at following specific instruction (i.e. written SOPs)

Working knowledge of cGMP/GLP

Good computer skills including word processing and working with spreadsheets

Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive

inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

Notice to Agency and Search Firm Representatives:

Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

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About Us

Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S. We are the eighth-largest generics pharmaceutical company in the U.S., and we are rapidly ramping up our presence in the specialty branded market, with dermatology, ophthalmology, and oncology as key target segments.

Our Values

Sunology, a combination of Sun and Ideology, is the way of life at Sun Pharma. We practice humility, integrity, passion, and innovation.

How We Work

With people at our core, Sun Pharma has built an inclusive and collaborative work culture, where all employees are empowered to pursue their dreams and professional aspirations.

Create Your Own Sunshine

Create Your Own Sunshine

At Sun we empower our employees to be Better Everyday, Take Charge and Thrive Together.

Benefits

Health & Wellness

We offer comprehensive benefits, including medical, dental, and vision coverage, as well as health and wellness programs.
Financial

We provide a competitive 401(k) match program and financial wellness programs to support our employees’ short- and long-term financial goals.
Life, Work & Family

We provide work-life benefits that support our employees beyond their workday.