Project Manager

Aphena Pharma Solutions is looking for a Project Manager to join our team in Easton, MD! Aphena Pharma Solutions is a dynamic pharma solutions provider focused on contract packaging, repackaging and manufacturing for the pharmaceutical, OTC, dietary supplement, animal health and medical device marketplaces.

Position Overview
The Project Manager is responsible for the daily coordination of project management activities related primarily to regulated products including costing, new product manufacturability, launch, existing product changes, and creation/modification of Product Master Records.  Project Management responsibilities extend from customer contract through transfer to commercialization post product launch.  In addition, the position will perform analysis functions including cost/benefit analysis and cost estimation functions prior to contract, including cost sensitivity analysis to changes in input variables as relating to new product launches and initial review immediately following launch.  The position will advise various other departments on issues related to new product opportunities, project launch activity status, and product changes.  This position reports to the Manager, Project & Product Management who will define specific customers and or project responsibilities for this position.

Position Responsibilities

• New Product Analysis
  • Work with Operations, Engineering, Purchasing, Tech Services, Laboratory, and QA to determine feasibility of new products or product modifications.
  • Develop Phase I and Phase II costs for products deemed feasible.
  • Coordinate the production of samples for initial customer evaluation as related to new product launches.
• Project Management
  • Manage/Coordinate all project management activities related to new products and existing product changes in a multi-departmental (matrix organization) environment
  • Schedule and lead project team meetings to ensure timely execution of action items.
  • Work with other departments to ensure that sufficient resources are available for timely execution of projects.
  • Coordinate with customers as required.
  • Create and maintain project timelines and ensure all stakeholders are updated on progress.
  • Review and disseminate project requirements both internally and externally ensuring that the appropriate departments have access to project scope and requirements   
• New/Modified Product Launches
  • Coordinate all development and documentation activities for regulated products (contract and Aphena owned), ensuring compliance to all regulatory requirements (US and overseas).
  • Coordinate the creation of all materials required by customers for regulatory submissions. 
  • Responsible for timely, accurate development of Product Master Records.
  • Provide guidance in the creation of Master Batch Records as appropriate.
  • Ensure that all aspects of Product Realization are completed, as appropriate.
  • Lead risk management activities for assigned projects.
  • Provide guidance on feasibility activities.
  • Assist with development of strategy and coordinate performance of process validation activities.
  • Assist with development strategy and coordinate performance of cleaning validation activities.
  • Responsible for reviewing, negotiating, documenting and controlling all customer supplied specifications.
  • Assist with tech transfer from customers to Tech Services, Validation, and Laboratory.
  • Document Scope Change from initial product analysis activities and provide impact to the organization.
• Total Cost Productivity
  • Assist with standard cost review and update.
  • Work with Purchasing, Operations, and Engineering to drive specific, targeted cost reduction projects.
• Other:
  • Other duties and responsibilities as assigned.
     

Personal Attributes

• Individual must be a highly motivated self-starting team player that can successfully manage multiple priorities in a timely fashion with a minimum of supervision.
• Ability to plan and organize non-structured objectives into structured projects and tasks.
• Ability to manage large, complex, technical projects.
• Ability to coordinate with extremely technically oriented customers and regulatory agencies.
• Excellent written, organizational and communications skills.
• Ability to interpret an extensive variety of technical product information including drawings and written specifications.
• Demonstrated analytical ability including the ability to perform semi-sophisticated mathematical manipulations.
• Highly developed interpersonal skills; proven ability to work with and leverage other people.
• Integrity, strong business ethics.
• Change leader.
• High level of energy and enthusiasm.
• Attention to detail.
• Professional manner.
• Strong work ethic.
• Impeccable ethics.
• Dependable.
• Trustworthy.
• Able to handle stressful situations.
• Overtime as needed to support needs of position.

Physical Requirements

• Most of the job is sedentary, however, occasional periods of light to moderate work may be required, lifting up to approx. 50 lb. occasionally
• The worker will be exposed primarily to inside office conditions, but Operations and warehousing environments may occasionally be encountered.  
• Other physical requirements will include, but may not be limited to, the following physical activities:
  • Oral and written communication - employee must be able to receive, understand, and communicate verbal and written instruction and communicate in the English language.
  • Visual acuity appropriate for a normal clerical-type position
  • Hearing,
  • Fingering,
  • Grasping,
  • Pushing, pulling, lifting, reaching, - occasionally
  • Bending, stooping, kneeling, - occasionally
  • Climbing stairs - occasionally
  • Walking - frequently
• Drive a vehicle.
• Occasional travel may be required (<25% of the time).
• Employee will occasionally be exposed to odors, dust, and fumes and noise.
• Employee will occasionally be exposed to outside environmental conditions.

Education/Experience

• Education:
  • High School Diploma or equivalent.
• Experience:
  • Strong knowledge and understanding of Pharmaceutical cGMP and/or medical device cGMP
  • Strong MS Word skills.
  • Strong MS Excel skills.
  • Good working knowledge of MS Outlook and PowerPoint.
  • Demonstrated Project Management skills required.
  • Specific knowledge of MS Project preferred.
  • Demonstrated understanding of general business processes and principles is required.
  • A minimum of 2 years of experience in a Project Management or similar position, preferably in a manufacturing environment.
  • Cross-functional experience with knowledge of Operations and cost analysis strongly preferred.
  • Demonstrated team management and participation skills required.