1+ months

Sr Manager, Manufacturing

Rockville, MD 20850
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Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I. JOB SUMMARY

The Sr. Manufacturing Manager position is responsible for Line A and B fill/finish manufacturing operations encompassing formulation, filling, capping, inspection, and labeling & packaging. This includes management of manufacturing staff, manufacturing budgets, developing standard operating procedures and training, interacting with other departments and being on-call during critical process operations.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Provides hands-on management/supervision of manufacturing staff in the fill/finish operations involving with preparations, formulation, filling, capping, inspection, labeling and packaging.
Involved as manufacturing SME in technology transfer for new product introduction and process optimizations. This includes supporting Validation, Engineering and Facilities personnel in start-up, testing and operation of manufacturing process equipment
Will lead support groups on establishing/maintaining production schedule and performance metrics and goals
Establishes performance standards and goals for Manufacturing Supervisors and Associates
Demonstrates and enforces understanding and adherence to Emergent policies, GMP standards and safety procedures
Hires, evaluates, trains, develops and terminates staff
Oversee development and maintenance of management processes including, but not limited to: Employee job descriptions, Integrated Performance Management Process (IPMP) documentation, staffing models, resource allocation models.
Effectively delegate decision making into the department. Empower direct reports to make level-appropriate decisions.
Updates site leadership team on process status and achievement of objectives
Resolves problems of manufacturing staff and manages manufacturing resources
Develops and maintains manufacturing budgets
Frequently Interacts with other site group leaders including Sr. Director and VP level staff
Prepares and conducts technical presentations of manufacturing processes
Performs annual performance appraisals of staff reporting to the position
Generate Batch Records, SOPs and Protocols as required
Reviews Batch Records, SOPs and Protocols as required
Verifies manufacturing readiness including raw materials, staff training, suite cleaning and equipment operation
Responds to or delegate duty as primary, manufacturing alarm response representative according to site alarm response policy
Works with subject matter experts to trouble-shoot and/or optimize processes as required
Supports Emergent QA during audits and regulatory inspections


The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects managements assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

BS degree in biology, chemistry or related scientific discipline
Minimum 8 years of GMP pharmaceutical experience
Minimum 5 years supervisory experience
Experience in contract manufacturing operation of managing drug (small molecule), biologic, and vaccine development projects including technology transfer
Excellent written and verbal communication skills
Computer literate (Word, Excel and PowerPoint)

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy<> .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actionswhether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the communitywe strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.

Industry

  • Biotechnology
Posted: 2022-07-08 Expires: 2022-10-23
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Sr Manager, Manufacturing

Emergent BioSolutions Inc.
Rockville, MD 20850
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