Sr. Process Development Engineer (Biologics)

Summary:
Designs, develops, and transfers manufacturing technology into clinical and commercial operations for PEGylated proteins. Provides expertise in process development and engineering including design, characterization, scale-up, optimization, technology transfer and validation. Introduces new  processes and technology from the laboratory to manufacturing. Assists manufacturing operations in problem solving to achieve cost effectiveness and improved product quality. Establishes product and process requirements for new process equipment. Interfaces with various departments to ensure processes and designs are compatible for new product requirements and to establish future manufacturing technology. May provide oversight on all aspects of non-GMP/GMP manufacturing activities for several Biologics clinical programs primarily internally, but occasionally at contract manufacturing sites (CMOs).  This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Essential Duties and Responsibilities:
Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.  Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results.  Creates formal networks involving coordination among groups. Uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Determines methods and procedures on new assignments. 
•    Leads projects and determines resources with senior management input. 
•    Assists in the determination of departmental objectives and their achievement. 
•    May represent the department on core teams and act as a Team Lead. 
•    May work in a cross-functional team consisting of internal and external partners to ensure effective application of process technologies at internal and CMO sites. 
•    Builds executable cross functional plans for projects and may supervise staff on projects. 
•    May draft and review regulatory filing sections. 
•    May draft technical protocols and reports.
•    Plans and may oversee non-GMP production strategy  including resourcing, timing, training, and supplies. 
•    Resolves most issues on studies and prepares complex reports. 
•    Prepares cross functional instructional SOP's, batch documentation, and explores system level improvements. 
•    Develops process development plans for projects. 
•    Balances program team needs with corporate requirements and process requirements. 
•    Establishes equipment specifications and concepts. 
•    Provides process perspective to equipment design reviews. 
•    May provide guidance to technical staff. 
•    Other duties as requested.

Minimum Qualification Requirements:
A minimum of a Bachelor's degree in an engineering discipline is required. Equivalent experience may be accepted. A minimum of 8 years industry work experience is required. Must have 5 years of experience in a GMP, development, operational or manufacturing environment.  Must have experience with manufacturing scale column chromatography and ultrafiltration/diafiltration. Must possess excellent technical judgment and use structured decision-making techniques.  Must be a team player with excellent interpersonal skills.  Project management skills are highly preferred.  Excellent communication skills, both written and oral are required.  Experience in early-stage development programs and technology transfer is preferred. A working knowledge of regulatory requirements for pharmaceutical industry is required. Demonstrated technical writing skills in support of regulatory filings is a plus.  Experience with electronic quality management systems, opening deviations, change controls, and CAPAs is preferred. Must have an ability to provide technical engineering support in a collaborative, team-oriented project environment.   Good documentation and record keeping skills and attention to detail are essential.

Key Words: Engineering Bioprocess Chemical Downstream Processing Biologics