Operations Project Manager

Our client is a specialty pharmaceutical company.  They have asked us to assist them in their search for an Operations Project Manager.  This position reports into the Director Supply Chain Management.

The Operations Project Manager will manage all domestic and international product launches and the multiple tasks involved.  He/She will lead and/or provide support for internal and external projects such as but not limited to new equipment qualifications, alternate material qualifications and commercial product launches.  The Manager will assist in the preparation and review of functional protocols, reports and SOPs and will interface as a liaison between Operations and all internal departments relative to new non-commercial/commercial projects/products.  The Manager will establish and maintain professional relationships with company business partners serving as primary liaison where appropriate, and will promote, develop, and nurture project teams so as to facilitate, manage, and direct special projects both internally as well as with business partners and vendors.  He/She will represent Operations (Engineering, Manufacturing, Purchasing, and Supply Chain) in portfolio teams where a product is being prepared for commercialization, and lead project teams and functions as primary advocate of project where assigned.

Essential duties include:

Manage functions of projects relating to Operations, such as:

• All product launches or re-launches (Domestic and International Products)

• Communicate within Operations, (Manufacturing, Purchasing, Engineering, Supply Chain), so as to assure maximum project efficiency and compliance. 

• Assist in the development of strategies for launch

• Manage details relating to product introduction

• Develop Operations product launch/project timelines, which highlight and track the activities of the project from inception to completion or launch.

• Liaison with  Logistics on the distribution of product launch quantities (Domestic and International)

• Liaison with Labeling and Package Design and Package Engineering to assure packaging development and implementation  that complies with equipment  parameters as well as marketing strategies
• Interact and foster cooperative working relationships that facilitate project tasks with internal partners and project members to ensure maximum product-to-market efficiency
• Coordinate department meetings and attend project team meetings ensuring communication and organization.

Serve as liaison between Operations and other internal departments in the execution and development of commercial and non commercial projects coming to Manufacturing.

Review, revise and implement departmental SOPs so as to facilitate a more effective, consistent and valid process of executing and managing projects, product launches, technology transfer, etc.

Promote “team" atmosphere between all functional departments as well as cross-functional teams with corporate partners.

Perform other duties and special projects relating to Operational Processes and Projects, as assigned.

Approximately 10 days of overnight travel per year.

We seek candidates with the following qualifications:

• Bachelor’s degree Chemistry or related field of study.  

• Four years or more, professional experience in regulated environment; 

• Knowledge of FDA regulations, cGMP is required; 

• Experience in writing SOPs, Protocols and Investigations is a plus.  

• Experience in pharmaceutical (transdermal is a plus) manufacturing and/or pharmaceutical related processing (ex. packaging). 

• Experience in manufacturing Technical Services, Engineering or Validation is a plus 

• PC literate with high proficiency in office application software including Excel and MS Projects or equivalent.  

• Excellent written and verbal communication skills; 

• Able to establish and maintain professional relationships.  Professional and customer service demeanor. 

• Project management experience with keen attention to accurate details. 

• Experience in Product Formulations/Development, Product Transfer, Packaging Design and JD Edwards experience a plus.

• Must have excellent organization skills, verbal and written communication skills, and decision making skills.  Must lead by example.

Do you have the skills and experience we seek and want to advance your career with a growing, innovative company?  If so, please email your resume as a Word attachment to [Click Here to Email Your Resumé], reference code 2354-CB.  No calls or faxes, please.  Include your daytime phone number and we will contact you confidentially or reply to your email.