Process scientist job description

Come Be Part of a Mission that Matters!

Neogen seeks a candidate for our Process Control Scientist position. This candidate will be responsible for performing testing on components and finished kits produced in the Immunodiagnostic and Microbiological Products. Assist with product troubleshooting and problem solving. Collect and format data. Assist senior staff with new product transfers from Research and Development, preparing them for eventual full-scale manufacturing and eventual transfer to the appropriate manufacturing department.

Essential Duties & Responsibilities:

* Formulate chemical reagents from stock with direction from the appropriate Standard Manufacturing Procedure (SMP) or Standard Operating Procedure (SOP).
* Use good manufacturing procedures (GMP and ISO) in the manufacture of all components.
* Ensure documentation complies with cGMP and ISO requirements; gives feedback to improve the documentation.
* Assist in testing processes and subassemblies based on approved experimental designs.
* Participate in validation and verification procedures pertinent to product transfer.
* Assist in testing the robustness and manufacturability of the product during transfer.
* Participate in product/process improvement of current products to improve product quality, reduce lead-times and improve costs.
* Executes and maintain Standard Operating Procedures to meet current cGMP / ISO / MIOSHA / MDEQ or other regulatory requirements.
* Prepare and present reports and analysis of data as required.
* Maintain general cleanliness and organization of physical space.
* Assist in troubleshooting quality problems with products made in Lansing.
* Other duties as may be assigned by Management.

Education and/or Experience: College education - degree in Protein Chemistry, Chemistry, Biochemistry, or related field. One to two years related work experience or college laboratory experience.

WHO IS NEOGEN:

From farm to fork, we offer solutions to enhance the quality, quantity and safety of the global food supply. Our food safety diagnostics are used within farming operations to the production facilities of most of the world's best-known food companies. Neogen's solutions are critical to the health and well-being of our customers' operations - and in turn their consumers. What we do matters!

Neogen's culture combines stability with a deep believe in providing professional and personal growth. Our Pillars of Trust - the principles which guide our everyday decision-making, include Openness, Honesty, Credibility, Respect, and Service. It's the belief in these characteristics that provide a consistent, happy and healthy work environment for our employees.

• A PhD in Synthetic Organic Chemistry or a related discipline with 0-2 years of relevant post-graduate process chemistry experience in the Biotech or Pharmaceutical industries (post-graduate academic experience will be considered); or MSc in Synthetic Organic Chemistry or a related discipline with 5+ years in process chemistry experience
• A strong background organic chemistry, with emphasis on solid-phase oligonucleotide or peptide synthesis experience is preferred
• Experience with scale up or process chemistry is preferred
• Experience with reverse-phase and ion-exchange purification and LC-MS characterization techniques is valuable
• Experience with troubleshooting synthetic reactions and solving synthesis issues is highly desirable
• Experience preparing standard protocols
• Experience maintaining relationships with CROs/CMOs and vendors is a plus
• Excellent communication (written and verbal) and interpersonal skills
• Experience working independently with guided supervision and collaborate with other groups
• An understanding of project timelines and coordinating experiments to meet team objectives

The Perks

By becoming a team member here at Entrada, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.

Third Party Staffing Agencies

Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.

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**Why Patients Need You**

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

**What You Will Achieve**

You will have knowledge of process equipment and systems and manufacturing operations with the primary responsibility to execute process and equipment operation activities during manufacturing operations. Due to your expertise in the manufacturing domain, you may participate in training for operational qualifications and assist the Team Lead or other team members as needed. You will conduct all activities in accordance with Company policies and standard operating procedures, Pfizer Values, and global regulatory guidelines, environmental guidelines etc.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

**How You Will Achieve It**

+ Contribute to completion of project milestones and organize own work to meet project task deadlines.

+ Use operational and technical expertise to assist in troubleshooting activities, technology transfer and start-up activities.

+ Monitor the technical documentation for the production and processes approval.

+ Ensure all production equipment and systems are in compliance with {Current} Good Manufacturing Practices.

+ Manage execution of relevant process activities by following established Standard Operating Procedures.

+ Perform process monitoring and data analysis, and data preparation for presentation in several forums including project team meetings.

**Qualifications**

**Must-Have**

+ Bachelor's Degree

+ Effective verbal and written communication skills

+ Basic mechanical knowledge and the use of hand tools

**Nice-to-Have**

+ Experience within the pharmaceutical industry

+ Experience with Six Sigma or other operational excellence programs

**PHYSICAL/MENTAL REQUIREMENTS**

+ Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs.

+ Must have the ability to lift ~50 pounds.

+ The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam and/or corrosive chemicals.

+ The incumbent is required to attain detail knowledge of the operational equipment.

+ The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing.

+ The incumbent must be able to express ideas into SOPs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc

**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**

2nd Shift: 2PM - 2AM, Rotating

Work Location Assignment: On Premise

Relocation assistance may be available based on business needs and/or eligibility.

**Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.**

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Manufacturing

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