1+ months

Senior Project Manager (Device Combination Products)

Pfizer
Columbia, MD 21044
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**ROLE SUMMARY**

This position will assume a leadership role to manage new product development. In addition, this position will also manage projects to maintain existing Auto Injector products to be in compliance with regulations and or customer requirements. The position will be responsible to oversee the development and maintenance of project timelines and cost information and to work with the project teams to ensure execution to project plans meets expectations. The position will be responsible to assess risk, develop mitigation plans and to lead regular team meetings working cross functionally with the sites Manufacturing, Quality Assurance, Quality Control, Validation, Technical, Biomedical Technology and Regulatory departments. Interaction with colleagues outside the site and with customers will also be required. The position will report on a regular basis to the Sr. Director Biomedical Technology and the site leadership team. The new products and processes developed must allow for manufacturing to occur in compliance with cGMP's, regulatory standards, design controls, company policies and site processes. Responsible for adhering to design controls and documenting all product development work in a Design History File.



**ROLE RESPONSIBILITIES**

Manages key research and development projects utilizing effective project management tools.

Ensures project plans are developed and maintained to meet the needs of the site and customer using appropriate risk mitigation strategies.

Conducts routine project review meetings with team members to ensure timelines and projected costs are met.

Assess risk and ensures that issues are discussed within the team and with the sites leadership.

Manages projects to design controls per 21 CFR 820.30, 21 CFR 4, and company policies and procedures.

Drives project team accountability.

Ensures that the project teams interact with MMT and PFE Validation, Manufacturing, Quality, Technical and Regulatory departments, at appropriate levels, to ensure execution of project tasks.



**BASIC QUALIFICATIONS**

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

B.S. Degree in Engineering discipline with 5 - 7 years experience

Certifications: Project Management Professional (PMP) or similar.

M.S. Degree in Engineering discipline with 3 - 5 years experience

Ph.D. in Engineering discipline with 1 - 3 years experience

(Biomedical Engineering or Mechanical Engineering preferred)

A minimum of 5 years of pharmaceutical, medical device, or combination product development and/or manufacturing experience is required for this position.

Presentation skills, computer literate (MS Word, Excel, PowerPoint, Project; QTS; Lotus Notes)

Project management tools

PREFERRED QUALIFICATIONS

10 years of pharmaceutical, medical device, or combination product development and/or manufacturing experience is preferred for this position.

Knowledge of cGMPs and regulatory requirements as related to the manufacture, testing and quality of parenteral products.

Experience in complying with FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30 and EU Medical Device Directives

Experience and knowledge in the development of parenteral liquid drug products with device design controls, mold/tooling build and design for componentry, and combination product design/function will be required.

Strong mathematical, analytical, and reasoning skills

Strong problem solving skills

Strong innovation skills

Strong creativity astuteness

Strong research skills

Strong organizational skills

Strong in team work

Strong written and oral communication

Good interpersonal skills; collaborative approach; team player.

Demonstrates attention to detail.

Excellent organizational skills.

Ability to interact with senior leadership and regulatory agencies

Demonstrates self-sufficiency, able to work under limited supervision.

Experienced in meeting the expectations and requirements of internal and external customers.

Makes decisions of moderate complexity, sometimes with incomplete information and under tight deadlines and pressure. Makes sound decisions based upon a mixture of analysis, wisdom, experience, and judgment. Always acts with integrity.

Deals with concepts and complexity comfortably - intellectually sharp, capable and agile.

Understands when to inform, consult or escalate.

Summarizes information succinctly and accurately and provides clear recommendations based on a combination of the information at hand and regulatory/procedural guidance.

Manage Resources to meet organizational goals

Understanding of financial systems

Ability to perform GMP assessments for new & revised PQS

Ensure participation in company-wide knowledge exchanges



The job is open only to Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.



Last Date to Apply for Job: March 31, 2020

Eligible for Relocation Package: Yes

Eligible Employee Referral Program



**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.



Engineering
Posted: 2020-02-18 Expires: 2020-04-05

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Senior Project Manager (Device Combination Products)

Pfizer
Columbia, MD 21044

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