Mfg Logistics Technical Expert

2 weeks ago


Groton, United States Pfizer, S.A. de C.V Full time

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place. To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals. Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world. Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Transforming Delivery of high quality products PGS - Manufacture the Future Why Patients Need You Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Chemical Research and Development - Manufacturing (CRD-M), as part of Worldwide R&D in Pharmaceutical Sciences, is responsible for the implementation of process technology for the production of active pharmaceutical ingredients (API).

What You Will Achieve In your role, you will perform operations that are required for the production of

non-commercial size clinical batches for investigational study purposes.

As part of the Technical Operations team, you are recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will make decision about the methods and procedures that are the best fit for different work situations. You will train others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to our patients. We are seeking a Manufacturing Logistics Technical Expert to join the CRD Manufacturing team in Groton CT. As part of the Operations team, Technical Experts are involved in the coordination, execution and manufacture of novel clinical API supplies under GMP. The successful Manufacturing Logistics Technical Expert will perform operations to manufacture GMP API as described in the batch record and manage the waste characterization for disposal. The Technical Expert collaborates with engineers, chemists, process supervisors and analysts to execute project manufacture in the regulated manufacturing areas. Given the dynamic team environment, strong interpersonal and communication skills are essential.

How You Will Achieve It Subject matter expert to execute workflow and achieve alignment with CRD-M Process Supervisors on Hazardous Waste Characterization for Kilo Lab scale, batch and flow processes Single point of accountability for large volume chemical hazard identification prior to disposal Manage timelines in response to portfolio and technology demand prioritization Responsible for materials and consumables management/requisitioning to support facility operations as specified by CRD-M Portfolio Lead Under general supervision and working within defined operation parameters, conducts hands-on manufacturing of bulk organic synthesis in the Kilo Lab Utilizes cGMP procedures and safe handling techniques of reactive chemicals, intermediates, solvents and waste streams during processing Develop technical expertise of the design of the CRD manufacturing areas, equipment and utilities, the quality systems used in manufacturing, and the composition and workflows of the operations team Reads, understands and records all information in GMP batch records as well as laboratory notebooks and maintains accurate records with an absolute focus on quality, compliance and safety Sound grasp of basic mathematical calculations (e.g., ability to calculate volumes, areas and density conversions) is required Cleans and maintains mechanical and processing equipment as needed while supporting a GMP qualified maintenance program Process and equipment troubleshooting Qualifications Must-Have Minimum: High school diploma or equivalent and at least 6 years experience in manufacturing with a strong preference for experience with GMP API manufacturing Certification in assigned area if applicable. Knowledge of industry practice for cGMP. Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Problem solving and trouble shooting skills. Strong workload planning skills and organization. Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude Nice-to-Have B.A./B.S, in Science or Engineering, or equivalent Experience with Quality Management and Change Management Systems. Proficient knowledge of cGMP and process safety Mechanical aptitude a plus as this is a “hands-on” Experience with lab automation software (e.g. Delta V) Working knowledge of chemical engineering principles including; reaction kinetics, thermodynamics, heat and mass transport, and equipment design PHYSICAL/MENTAL REQUIREMENTS Position is full-time on a weekly rotating schedule: 1st shift (6:00am - 2:30pm) and 2nd Shift (2:30pm - 11:00pm), with overtime as needed. Ability to perform mathematical calculations Ability to lift 50 pounds Why Patients Need You Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Chemical Research and Development - Manufacturing (CRD-M), as part of Worldwide R&D in Pharmaceutical Sciences, is responsible for the implementation of process technology for the production of active pharmaceutical ingredients (API).

What You Will Achieve In your role, you will perform operations that are required for the production of

non-commercial size clinical batches for investigational study purposes.

As part of the Technical Operations team, you are recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will make decision about the methods and procedures that are the best fit for different work situations. You will train others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to our patients. We are seeking a Manufacturing Logistics Technical Expert to join the CRD Manufacturing team in Groton CT. As part of the Operations team, Technical Experts are involved in the coordination, execution and manufacture of novel clinical API supplies under GMP. The successful Manufacturing Logistics Technical Expert will perform operations to manufacture GMP API as described in the batch record and manage the waste characterization for disposal. The Technical Expert collaborates with engineers, chemists, process supervisors and analysts to execute project manufacture in the regulated manufacturing areas. Given the dynamic team environment, strong interpersonal and communication skills are essential.

How You Will Achieve It Subject matter expert to execute workflow and achieve alignment with CRD-M Process Supervisors on Hazardous Waste Characterization for Kilo Lab scale, batch and flow processes

Single point of accountability for large volume chemical hazard identification prior to disposal

Manage timelines in response to portfolio and technology demand prioritization

Responsible for materials and consumables management/requisitioning to support facility operations as specified by CRD-M Portfolio Lead

Under general supervision and working within defined operation parameters, conducts hands-on manufacturing of bulk organic synthesis in the Kilo Lab

Utilizes cGMP procedures and safe handling techniques of reactive chemicals, intermediates, solvents and waste streams during processing

Develop technical expertise of the design of the CRD manufacturing areas, equipment and utilities, the quality systems used in manufacturing, and the composition and workflows of the operations team

Reads, understands and records all information in GMP batch records as well as laboratory notebooks and maintains accurate records with an absolute focus on quality, compliance and safety

Sound grasp of basic mathematical calculations (e.g., ability to calculate volumes, areas and density conversions) is required

Cleans and maintains mechanical and processing equipment as needed while supporting a GMP qualified maintenance program

Process and equipment troubleshooting

Qualifications Must-Have Minimum: High school diploma or equivalent and at least 6 years experience in manufacturing with a strong preference for experience with GMP API manufacturing

Certification in assigned area if applicable.

Knowledge of industry practice for cGMP.

Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Problem solving and trouble shooting skills.

Strong workload planning skills and organization.

Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude

Nice-to-Have B.A./B.S, in Science or Engineering, or equivalent Experience with Quality Management and Change Management Systems. Proficient knowledge of cGMP and process safety Mechanical aptitude a plus as this is a “hands-on” Experience with lab automation software (e.g. Delta V) Working knowledge of chemical engineering principles including; reaction kinetics, thermodynamics, heat and mass transport, and equipment design PHYSICAL/MENTAL REQUIREMENTS Position is full-time on a weekly rotating schedule: 1st shift (6:00am - 2:30pm) and 2nd Shift (2:30pm - 11:00pm), with overtime as needed. Ability to perform mathematical calculations Ability to lift 50 pounds

Work Location Assignment:On Premise

The salary for this position ranges from $31.82 to $53.04 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - Connecticut - Groton location. Relocation assistance may be available based on business needs and/or eligibility. 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. This position requires permanent work authorization in the United States. Manufacturing

Breakthroughs that change patients’ lives

Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world. Each word in our purpose has meaning and reflects the value we strive to bring to patients and society: “Breakthroughs”

- These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day. “Change”

- We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better. “Patients’ lives”

- We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view. Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies. Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive. Our Values

To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals. The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture. Courage:

Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive. Excellence:

We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes. Equity:

We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities. Joy:

We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun. Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world. With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need. Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide. Benefits at Pfizer

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business. Our Competitive Benefits Programs help our colleagues by: Promoting Health and Wellness

to help colleagues maintain and improve their physical and mental

wellbeing . Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness

counseling

and more. Strengthening Colleagues’ Financial Security

by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals. Providing Benefits and Time off for the Moments that Matter

to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs. And so much more , depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness

centers , movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.

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