Description:
The individual is responsible for the execution of process transfers and launch implementation activities associated with moving production of Transfusion Medicine Products from their current manufacturing location to alternate sites.
The individual must ensure that key project milestones are met to ensure the overall project goals are met and continuity of supply to customers is maintained.
Major Duties & Responsibilities
Briefly describe, in sentence form, the essential functions/major responsibilities of this position (principal duties and responsibilities of the position) as it exists today. Describe the job, not the person in the job. Each item listed below should be an essential function/major responsibility of the position, not a day-to-day activity.
percentage of time to least.
% of Time Tasks/Duties/Responsibilities
30% Author Tech Transfer deliverable checklists to ensure that all prequisite requirements are in place prior to manufacturing the verification (Transfer), Validation and launch lots of products. Ensure all objective evidence and supporting evidence is obtained and meets requirements.
30% Ensure receiving site protocols and reports are aligned to the manufacturing transfer plans and that transfer and validation lots meet requirements.
25% Author /update Manufacturing Transfer Plans and Reports related to the alternate site(s)
10% Serve as liason between the current and new manufacturing locations as required.
5% Ensure that all documentation and any updated versions are provided to the alteranate manufacturing locations.
Perform other work-related duties as assigned.
100% Total
Qualifications
Consider and identify qualifications potential applicants must possess in order to be considered for the position and those that are not required to perform the job but would be very helpful to performing the job.
Minimum Education or Equivalent
Experience Required/Preferred Degree in Chemistry, Biochemistry, Biology or similar discipline preferred or minimum of 5 years experience in an Tech Transfer, Operations or Product Development/Support role within a GMP manufacutring facility.
Minimum Years of Related Knowledge,
Skills and Abilities Required/Preferred
Minimum of 5 years experience in an Operational or Technical environment Demonstrated ability to successfully deliver aProductst project timelines Track record of contributing to cross-functional teams within a regulated environment.
Required travel % (identify if domestic and/or international) Predominately site based, less than 5% domestic or international travel per year
Key Working Relationships
Identify the most important working relationships with people inside and outside the company including customers, vendors, associations, etc. Briefly describe the nature of the contacts. Internal Operations, Quality,Supply Chain, Raw Material supply, Engineering, R&D
External External Manufacturing Supplier, External Supplier
Supervisory Responsibilities
List number of employees reporting to this position, both directly and through direct reports.
Direct Reports None Indirect Reports None