Environmental Health & Safety Engineer

San Jose, CA, United States

About Cipla

Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.

Driven by the purpose 'Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.

InvaGen Pharmaceuticals, Inc.

InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla's respiratory business in the United States.

Job Title

R&D Scientist

Organization Name

InvaGen Pharmaceuticals

Location

550 South Research Place Central Islip, NY 11722

Employment Type

(Hourly/ Full Time)

Full Time - Salaried/Exempt

Salary Range

(Base/ Hourly)

$80,000 - $110,000

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits

Work Hours/ Shift/ Remote

8:30 AM - 5:00 PM

Responsibilities/ Accountabilities

The 'R&D Scientist, Sterile Injectable/Parenteral/Solid Oral Formulations' position is an individual contributor role and reporting to the Director of Research & Development (R&D) at InvaGen/Cipla New York. The job duties for this position include but are not limited to the following:

Operate as the subject matter expert (SME) on pre-formulation and formulation, process development and technology transfer as applied to sterile injectable / parenteral formulations. Products may range from vials, ampoules, infusion bags, pre-filled syringes etc. for the parenteral dosage form and tablets, capsules, sachets etc. for the oral solid dosage form.

Lead formulation and process development, product characterization, process analytical technologies (PAT) and incorporation of active pharmaceutical ingredients (APIs), excipients, packaging material and devices to develop finished products. Products may range from internal product development projects, products that are commercialized, products that are in-licensed from external entity or products that are co-developed with a development partner.

Conduct API, excipient, packaging, or device characterization; excipient compatibility and forced degradation studies. Recommend stage appropriate acceptance criteria for vendor and regulatory specifications. Utilize relevant theoretical modeling and statistical tools, as required.

Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE). Recommend stage appropriate acceptance criteria. Utilize PAT where feasible. Utilize relevant statistical tools, as required.

Review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction. Develop and implement strategies to control related substances, where applicable.

Work with relevant cross-functional stakeholders (e.g., Commercial Operations, Quality Control, Quality Assurance etc.) on scale-up and technology transfer of processes from R&D to commercial functions.

Lead and/or participate in activities related to process development, process verification/qualification, process pre-validation, process validation, site and equipment qualification in collaboration with relevant stakeholders.

Act as single-point technical contact for contract development and manufacturing organizations (CDMOs) or contract research organizations (CROs). Collaborate with project management (PM) function to lead execution of activities against approved plan.

Provide relevant subject matter expertise in collaboration with external partners in the form of participation in technical strategy discussions; consultation on technical studies; hands-on characterization and/or third-party interface (e.g., CDMOs, CROs etc.)

Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).

Lead and/or participate in conducting data and hypothesis driven investigations for quality events (planned and unplanned deviations) with recommendations of relevant corrective and preventative actions (CAPAs) to line functions.

Independently draft and/or review standard operating procedures (SOPs).

Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders.

Draft and/or participate in drafting relevant sections of dossiers towards 505(b)(1), 505(b)(2) or 505(j) submissions. Lead studies in support of responses to United States Federal Drug Administration (FDA) information requests or deficiency letters for various dossiers.

Train peers and junior staff members on new techniques.

TYPICAL DAY-TO-DAY ACTIVIES

New product development

R&D activities such as pre-formulation, formulation, process development

Primary Packaging development and optimization

Technical Troubleshooting

Technology Transfer

Process Validations

Leading activities at CDMOs

Drafting dossier supportive documents

Drafting and responding to relevant requests from the US FDA or EU authorities

Working with external partners on technical activities

Education Qualifications

Doctorate in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.

Experience

Experience with basic concepts of sterile injectable / parenteral products is a must.

In-depth understanding of Industrial pharmacy, physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must.

In-depth understanding of various pre-formulation and formulation studies including excipient compatibility, forced degradation studies and unit steps in formulation manufacture is a must.

Experience with pilot-scale and manufacturing-scale equipment is a plus.

Experience with process analytical technologies (PAT) is a plus.

Experience with drug-device combination basics and operational aspects in a plus.

Experience with selection of primary packaging options is a plus

Skills/ Competencies

Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.

Strong command over written and verbal English is a must. Past publication experience is a must.

Must be able to work under minimal supervision and able to work independently and in a team environment.

Must be able to exercise appropriate professional judgment on matters of significance.

Must be proficient in computer skills and software applications such as Microsoft Office tools.

Knowledge of statistical packages is a plus.

Must communicate clearly and concisely across levels, both orally and in written

Physical Requirements

Work standing or walking unassisted for 75% or greater of an 8-hour period.

Unassisted lifting up-to 10 kg, may be required.

Able to wear appropriate personal protective equipment at all times, when required.

Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period.

Other Information

Relocation negotiable.

Employment sponsorship negotiable.

No remote work available.

Must be willing to work some weekends based on a relevant business need, if required.

Equal Opportunity Employer

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.

About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.

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