Senior manufacturing specialist job description

At Greene, Tweed, you'll find the cutting-edge technology, world-class polymer expertise and endless advancement opportunities you'd expect from a multi-national industry leader. You'll find them all in an environment that embraces diversity in people and opinions, moves decision making to the point of impact, and celebrates your success.

If you enjoy continuous learning and are excited about working with and creating technological solutions, explore career opportunities with Greene, Tweed.

Essential Duties/Responsibilities: Develop and maintain SAP Material Data, Routings and Bill of Materials for all products in manufacturing facility and corresponding sales areas. Maintain agreed upon metrics and service levels for key responsibilities in accordance with ISO and Quality requirements. Creates router, master templates and maintains manufacturing rates used in creating and maintaining routing. Extensive knowledge and understanding of manufacturing process and corresponding structure and setup in SAP is required. Provide manufacturing quotes for all products: standard and custom. Ability to develop and maintain automated quoting tools for standard products. Define and maintain standard work for all key processes in Methods, such as Material Master, Routing and BOM creation, Quoting process, ECN change management, etc. Based on above responsibilities, provide training for all new and existing Methods Specialists to assure consistency. Review Manufacturing Related Engineering Change Notices (ECN) and other change requests to assure accurate manufacturing data relating to SAP routing, BOM, Item Master data. Trained in all mass update capabilities for Master Data: MM, Routing, BOM. Ability to perform data analysis to maintain master data, such as assembly scrap analysis, labor rate analysis for productivity and efficiency rates through SAP reporting and analysis tools such as Excel.

Required Minimum QualificationsEducation/Certifications: HS Diploma required; Preference given to candidates with BS degree

Skills and Experience: 4+ years' experience working with master data, process routings and product quotes Extensive knowledge of manufactured manufacturing specifications, manufacturing equipment, process flow routings, bill of materials for assemblies, and standard manufacturing rates & costs for standard products is required in this position. Extensive knowledge of SAP Material Master, Routing and BOMs (or equivalent ERP system) required Demonstrated ability to read and interpret manufacturing prints required Job Environment:Physical Requirements:Standing Occasionally (16-45%) Sitting Frequently (46-100%) Lifting Up to 15lbs without assistance Carrying Up to 15lbs without assistance Walking Frequently (46-100%) Greene, Tweed Job DescriptionNote: This Job Description in no way states or implies that these are the only duties to be performed by the employeeoccupying this position. Employees will be required to follow any other job-related instructions and to perform any otherjob-related duties requested by the Supervisor. All requirements are subject to change and updates.Hearing Ability to detect noises with or without corrective device(s) Vision Clarity of vision, with or without corrective lenses Mental Requirements:Problem Solving Frequently (46-100%) Making Decisions Ability to make decisions that have a moderate impact Supervise Rarely (0-15%) Interpret Data Frequently (46-100%) Organize Frequently (46-100%) Read/Write Frequently (46-100%) Communication Frequently (46-100%) Work EnvironmentHigh Temperatures Rarely (0-15%) Low Temperatures Rarely (0-15%) Noises Loud (manufacturing environment, movement of large equipment) Fumes Exposure Rarely (0-15%)

Note: This Job Description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by the Supervisor. All requirements are subject to change and updates.

We offer a competitive benefits package that includes medical, dental, vision, life insurance, short term and long term disability insurance, 401K savings plan, paid time-off, tuition assistance and more, to meet the diverse needs of all employees and their family members.
EEO Minorities/Females/Protected Veterans/Disabled

Greene, Tweed, a Federal Contractor, is an equal opportunity employer of protected veterans and individuals with disabilities. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of disability or their protected veteran status.

NOTE: Greene, Tweed is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities, unless they have a written agreement for the position they are contacting us about. Regardless of past practice, all resumes submitted by search firms to any employee at GT without a valid written search agreement in place for that position will be deemed the sole property of Greene, Tweed, and no fee will be paid in the event the candidate is hired by Greene, Tweed as a result of the referral or through other means.

Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options.

What We Do:
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine and psychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis* and uterine fibroids*, as well as clinical programs in multiple therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. *in collaboration with AbbVie

About the Role:
Provides operational and technical support for commercial API Contract Manufacturing Organizations (CMOs) within the company's external global supply chain network with scope to potentially expand the role to include drug product CMOs in the future. Maintains and builds strong relationships and actively participates in assigned cross-functional activities relating to commercial manufacturing at API CMO sites. Contributes to activities related to the timely planning, scheduling, manufacturing and release of product. Participates in technical discussions and technical review of manufacturing documentation.
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Your Contributions (include, but are not limited to):
Collaborates with internal cross-functional teams and API CMOs to determine commercial manufacturing requirements, identify and mitigate key risks, and ensure that manufacturing plans are executed as intended Ensures on-time and predictable delivery of products and projects at assigned CMOsReviews pre- and post-production documents (e.g., master and executed batch records, protocols, technical reports), and manages the approval process for the same Participates in the operational activities (schedule, timelines, cost) of the CMOs, ensuring cost, quality, metrics, delivery and program objectives are met Provides Person-in-Plant coverage at assigned CMOs for critical production activities as/when needed Analyzes, identifies and recommends process improvement, and solutions to complex issues at the CMOsContributes to the execution of the supplier management process including relevant scorecards, to ensure appropriate controls, oversight and monitoring are in place Participates in the preparation of RFQs, RFPs, Statements of Work (SOW), and Supply AgreementsSupports validation activities at assigned CMOsPartners with Quality Assurance to ensure CMOs are compliant with all cGMP guidelines and Company SOP requirements Supports the optimization of spend at the CMOsWorks closely with Neurocrine chemical development and analytical chemistry colleagues during pre-commercial activities at CMOsOther duties as assigned

Requirements:
BS/BA degree in Engineering, Science or related field and 4+ years of Drug Substance Manufacturing, Process Development or Engineering experience in the Pharmaceutical industry. Experience with manufacture of solid oral dosage products, with an emphasis on drug substance operations. Direct experience with the manufacture of marketed products. Experience working in a cGMP-regulated environment, including knowledge of relevant US / EU regulatory and quality requirements, standards and practices ORMaster's degree in Engineering, Science, or related field and 2+ years of similar experience noted above Understands key business drivers and uses this understanding to accomplish work Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas Proficient with tools and processes that support work conducted by functional areas Ability to work as part of a team Excellent computer skills Strong communications, problem-solving, analytical thinking skills Detail oriented yet can see broader picture for department Ability to meet multiple deadlines, with a high degree of accuracy and efficiency Strong project management skills Demonstrated success in project planning, resource management, and collaboration with Development, Quality, Regulatory, and CMCExpertise in a cGMP-regulated environment, including knowledge of relevant US/EU regulatory and quality requirements, standards, and practices Strong knowledge of biotech/pharma manufacturing operations, and product and process development Familiarity with document management platforms, e.g. Veeva

#LI-DM1

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

As a condition of employment with Neurocrine Biosciences, Inc. in the United States, you must be fully vaccinated for COVID-19 and provide valid proof of vaccination to the company.

**ROLE SUMMARY**

The successful candidate will assume professional responsibilities within the API (Active Pharmaceutical Ingredient) compliance group. Primary responsibilities include managing all cleaning and process validation activities for their assigned manufacturing areas. In addition, the candidate must interface regularly with customer and regulatory auditors and take a lead role in evolving compliance programs with the API area and across the corporation.

Key responsibilities include:

+ Develop strategies and documents for cleaning and process validation of API equipment and products in compliance with site SOPs and regulatory guidance.

+ Support 24/7 plant operations with timely responses to complex validation concerns or cleaning failures

+ Defend the validation programs and strategies to customer and regulatory auditors.

+ Support API wide compliance initiatives.

+ Support corporate compliance initiatives.

+ Participate in and generate Quality Risk Management documentation.

+ Train and mentor colleagues in cleaning/process validation tasks.

**Qualifications**

**Must-Have**

+ Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience ORan associates degree with 6 years of experience OR a bachelors with at least 3years of experience OR Masters with more than 1 year of experience.

+ Work experience must include API manufacturing and/or cleaning/process validation.

+ Experience in collaborative working and problem-solving is essential

+ Understanding of regulatory standard and guidance documents as well as evolving cGMPS impact pharmaceutical production

+ Strong technical, analytical and problem solving skills with ability to make timely decisions

+ Change Agile, with willingness to learn and be challenged

+ **Physical Demands:** Frequent time in the manufacturing area around equipment with moving parts, stair climbing, roof access.

+ **Work Environment:** Office environment, with frequent time in the manufacturing. Use of hearing and eye protection is required.

+ **Technical Writing:** Demonstrated ability to write effectively with emphasis on technical content.

+ Role supports a 24 hour production environment. Primary responsibilities occur M-F during normal working hours. Some off hour and holiday coverage may be required. Must be available to support 24/7 - 365 operation.

**Nice-to-Have**

+ Prior experience with eQMS, gQTS, PDOCS, gLIMS, CoreLIMS, and SAP.

**PHYSICAL/MENTAL REQUIREMENTS**

• Physical Demands: Frequent time in both manufacturing and office environments. The manufacturing environment includes equipment with moving parts. Must be able to perform gowning requirements for entry in the manufacturing areas.

Requires lifting, sitting, standing, walking, stair climbing and roof access. Must be available to support 24/7 - 365 operation.

• Work Environment: Office environment, with frequent time in the manufacturing areas. Possible exposure to high noise environments, solvents, and pharmaceutical ingredients. Use of hearing and eye protection is required.

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

Role supports a 24 hour production environment. Primary responsibilities occur M-F during normal working hours. Some off hour and holiday coverage may be required. Must be available to support 24/7 - 365 operation.

Relocation support available

Work Location Assignment:On Premise

**Other Job Details:**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus

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