1+ months

Director, Manufacturing Ops (Prep, Form,Fill)

Baltimore, MD 21202


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 Director, Manufacturing Operations Preparation, Formulation and Filling (Filling), plans, directs and co-ordinates Camdens manufacturing Preparation, Formulation and Filling units, through subordinates, and in conjunction with other professionals internal and external to the company, formulate and fill drug product consistent with regulatory, sales and profitability requirements. This role also directs and coordinates the work efforts of a group of managers, specialists, manufacturing technicians, and bioprocess associates. Reporting to the Senior Director, Manufacturing operations, this Director sits on the Extended Site Leadership Team and has collective accountability to deliver against long range site plans.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Ensures manufacturing operations and drug product preparation, formulation and filling is consistent with regulatory, sales and profitability requirements by:

Consistency with corporate and Operations department strategic planning processes:
Executes against master production schedule and other plans to achieve production objectives.
Budgets and controls the financial, human and technical resources of the Filling operations; and
Develops and implements measures that provide feedback on Filling performance.
Maintains effective working relationships with professionals, internal and external to Emergent Camden, including all government agency and department stakeholders and the general public, by projecting a positive personal and corporate image through appropriate behaviors.
Aligns with the Supply Chain, Engineering, MSAT and OE teams to optimize Filling manufacturing performance, develops manufacturing improvement projects and leads their implementation and monitors the effectiveness of such strategies and plans to achieve management objectives.
Develops and maintains Filling manufacturing KPIs, utilizes management systems, and operating processes that adhere to internal and external quality, compliance and reporting requirements.
Recommends and, as approved, ensures changes to the structure and organization of tasks to ensure efficient achievement of accountabilities and goals and to provide flexibility to quickly capitalize on business opportunities.
As required, participates on internal audit and continuous improvement teams.
Participates in the review and analysis of potential contract manufacturing contracts.
Ensures the initial and continuing training of the departmental personnel is conducted and adapted according to need.
Ensures the safety and security of the departmental personnel, premises, and equipment.
Ensures adequate resources are budgeted for and administrative controls are adhered to.
Ensures every effort is made to complete annual goals that are agreed to with reporting manager.
Ensures that production records are evaluated and approved by an authorized person before they are sent to the Quality Assurance Department.
Ensures SQDEP KPIs are set, monitored, and actively addressed.
Accountable for ensuring compliance with the requirements of current Good Manufacturing Practices (cGMP).
Accountable for providing adequate resources through staffing solutions; this includes approval, selection, and monitoring of contractorsnalysts.
Performs or delegates the initial and continuing training of personnel.
In charge of regulating Camdens Filling manufacturing procedures/processes and assessing appropriate changes before implementation. Also responsible for having controlled, written responsibilities for the Filling department.
Establishes, implements, and maintains departmental procedures consistent with company policies and standards for hygiene, safety, and security to assure compliance with applicable regulations, guidance documents, and industry best practice.
Identifies, investigates, and reports to management issues which may affect product Safety, Quality, Delivery, Economics and People (SQDEP).
Possesses authority to delegate above tasks to trained members of the management team.

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
Education: Attainment of a university degree, either in the sciences, engineering, or operations, at a recognized university
Experience: Five to ten years directly related experience in a similar position, preferably in the biopharmaceutical sector.
Knowledge: Understanding of contemporary sterile drug product filling and manufacturing process, systems, controls and regulations is a core requirement. Demonstrated ability to resolve technical, scientific, and regulatory issues in the pharmaceutical industry and to effectively communicate such information to senior management.
Skills: Capable of utilizing Microsoft Office software (i.e. Excel, Word, PowerPoint, Project, Visio) to perform all required job duties.
Ability: Carries out management accountabilities in accordance with corporate policies and procedures. Accountabilities include recruitment, training and professional development, planning, assigning, and directing work, performance management and measurement and ensuring compliance with employment legislation.

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

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.

Categories

Industry

  • Biotechnology
Posted: 2022-01-21 Expires: 2022-07-22

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Director, Manufacturing Ops (Prep, Form,Fill)

Emergent BioSolutions Inc.
Baltimore, MD 21202

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