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Current positions available:
Senior Scientist/Manager of Purification and Bio-conjugation Development
Director of Operations
Business Development Manager
Senior Maintenance Mechanic
Quality Control Microbiologist
Senior Scientist/Manager of Purification and Bio-conjugation Development
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Department:
Business Development
Work Days:
M-F Full Time
Reports to:
Vice President of Process Development
Scope of Function:
1) Manage the development and transfer of Protein purification and protein Bio-Conjugation processes (involving monoclonal antibodies and recombinant proteins) from the client into process development and facilitating its transition into GMP manufacturing.
2) Perform relevant biochemical and biological assays
3) Lead the resolution of technical problems and training of personnel in the Process Development and Manufacturing Groups
4) Responsible for the transfer of purification and bio-conjugation processes to the manufacturing.
5) Effectively manage various projects, including resource allocation and ensuring that client timelines are met within the purification and bio-conjugation groups.
Specific Duties:
1) Manage all protein purification process development activities as they pertain to GLP and GMP standards. Including chromatography (e.g. affinity, IHC, IEC, Mixed bed, SEC) and filtration processes including sterile filtration, ultrafiltration, Diafiltration, and viral filtration.
2) Manage all protein bio-conjugation development activities pertaining to GLP and GMP standards.
3) Perform final product and in-process assays as required such as ELISA, SDS PAGE, IEF, HPLC, WESTERN, BCA, and other pertinent biological and biochemical assays as they pertain to GLP and GMP standards.
4) Participate in the qualification and validation of processes and as required
5) Write and execute design input and design output reports, SOPs, and batch records for newly implemented processes.
6) Lead the coordination of activities and communication to assure efficient and timely transfer of projects to the Manufacturing groups.
7) Assist Manufacturing Groups in trouble shooting processes were appropriate
8) Effectively interact and assist other groups within the Development group and the Quality, Manufacturing and Regulatory groups on purification bio-conjugation related matters
9) Interact with Clients and make recommendations and resolutions of processes being developed
10) Communicate project status with Clients, Project Management and Senior GBI Management as needed
11) Effectively manage and motivate lab associates in the purification and bio-conjugation development group
Education and Skills required:
Education: MSc or PhD in biological or biochemical sciences.
Experience: 6- 10 years relevant industrial experience in proteins and monoclonal antibody purification process and bio-conjugation development and GMP manufacturing, and protein characterization, particularly in the areas of immunology, molecular and cell biology and protein chemistry. Experience in protein and antibody purification and bio-conjugation development, qualification, validation and compliance is required. Experience with early to late stage GMP manufacturing is desirable.
Skills: This individual is considered an expertise in the area of antibody and protein purification and bio-conjugation development and therefore must be able to work independently with little to no direction. Must be flexible and able to work on multiple projects at the same time. Must be able to develop and implement to completion experimental protocols as they pertain to the duties listed above. Effectively manage the employees and the general operation of the lab. Good communication, documentation and computer skills.
Director of Operations
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Work Days:
M-F Full Time
Responsibilities:
This individual is responsible for all cGMP compliant Manufacturing and Facility Operations including cell culture, bioreactor operations, protein purification and final filling, Facilities and Materials Management.
Key areas of accountability include directing the activities of the responsible upstream and downstream manufacturing departments to assure projects are performed and completed in a manner that is acceptable to clients and GBI; ensures that operations departments follow cGMP, SOPs, and safety procedures as necessary and also ensures that all operations employee are properly trained for their job functions and that the training is documented in CGMP training records. It is expected that this individual will be intimately involved and hands-on activities for all GMP manufacturing, Facilities Operations and Materials Management group.
The Director of Manufacturing Operations will collaborate with Business Development, Process Development, Project Management, RA/QA/QC, and both existing and prospective clients to meet the requirements of each project. This individual will also be responsible for schedules for manufacturing activities and also prepare, review and approve written procedures, SOP’s, batch records, validation and other documents.
Qualifications:
Candidate will have a MS or Ph.D in engineering or biological science or related filed and a minimum of ten years in cGMP biologics manufacturing. Candidate must have a detailed working knowledge and hands-on experience of cell culture, bioreactor production, chromatography, ultrafiltration, and filling operations, and Facilities Operations. Experience in biologics manufacturing, preclinical, Phase I-III clinical manufacturing and/or commercial manufacturing is critical for this position. Knowledge of biologics manufacturing plant design, validation protocols, identification and specification of equipment, and operation are important.
Business Development Manager
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Department:
Business Development
Work Days:
M-F Full Time
Reports to:
Director of Business Development
Scope of Function:
Responsibilities include finding and developing new business opportunities and partnerships for GBI, continued development of ongoing relationships with current clients, and developing and implementing sales, marketing and advertising strategies.
Specific Duties:
1. Attract and develop new clients ensuring their needs are met in a timely and professional manner.
2. Provide advice and support to our prospective clients during the initial stages of relationship development, ensuring that every client gets individual, timely and professional support from their sales representative.
3. Insure that all documentation for clients related to BD, including but not limited to, CDAs, Pricing Estimates, SOWs, AFS and Quality Agreements, are completed quickly and to both GBI's and GBI's clients' satisfaction.
4. Solicit and complete RFPs on a timely basis. Ensure that GBI is in line to receive RFPs from new and existing sources on an ongoing basis.
5. Collaborate with Operations, Project Management, Quality, Finance and clients to meet the requirements of each project.
6. Develop and implement print and online advertising initiatives, including but not limited to, Google Ad Campaigns, Website Updates, Print Advertisements, Email Advertising Campaigns and Updated Company Literature.
7. Prepare and maintain sales/marketing department budgets.
8. Prepare schedules for Sales, Marketing and Advertising and Business Development related activities, including conferences and sales trips.
9. Work the territories of North America and solidify existing cross-referral agreements and recommend additional selling resources when advisable.
10. Advise Executives and Operational group as to the needs/wants of the marketplace in terms of services and capacity requirements.
11. Continuously update the company's competitive intelligence data base and be responsible for anticipating the strategic direction of key GBI competitors, to the extent possible.
Skills and Experience:
Education: Minimum BS in Biological Science or related field.
Experience: Minimum of 2 years experience in business development for cGMP manufacturing services (CMO) or a related field.
Experience with developing and implementing marketing and advertising strategies desirable.
Experience writing and negotiating high level contracts, from one time agreements to multi-year supply contracts.
Skills: Must possess excellent presentation skills.
Senior Maintenance Mechanic
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Work Days:
M-F Full Time
Reports to:
Facilities Manager
Scope of Function:
Senior Maintenance Mechanic is responsible for ensuring all mechanical equipment at GMP manufacturing facility are in working order and meet GMP qualification requirements. Provide mechanical support to operations and QC laboratory in equipment and instruments.
The candidate for this position need to have experience in Clean Steam Generators (CSG), Mechanical Seals, and manufacturing equipment like bioreactors, bioprocess skids, etc.
Education:
Associate in Mechanical, Chemical or Electrical Engineer and at least 5 years experience in a GMP environment. Bachelor’s degree is preferred. It’s preferred a candidate with training courses in the maintenance activities described above.
Experience:
The candidate for this position needs to have proven ability to perform maintenance qualification for manufacturing and analytical equipment in GMP biologics manufacturing environment. It’s required to have extensive experience maintaining utilities system including Clean Steam Generators (CSG), Plant Steam Generators (boilers) Emergencies Generators, and biotech manufacturing equipment.
Experience performing maintenance qualifications on analytical equipment in biological QC laboratories is preferred. A candidate must have at least 5 years experience in FDA Current Good Manufacturing Practices CFR 210 and 211.
Quality Control Microbiologist
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Reports to:
Quality Control Microbiology Supervisor or higher.
Scope of Function:
Responsible for all aspects of tests relevant to microbiology Lab. Assist Quality Control Microbiologist Supervisor in all the activities performed in micro lab.
Specific Duties:
1) Monitor all clean room environments throughout the facility, viable and non-viable.
2) Perform all the tests relevant to microbiology lab as required (Sterility, Bioburden, LAL, TOC, etc).
3) Assure accuracy of SOPs relating to Microbiology, including creation and revision.
4) Document and maintain lab notebooks.
5) Assist in ordering / inventory of lab supplies.
6) Keep Microbiology area in a tidy, organized, and sanitary condition.
7) Assist in qualification/validation process related to Microbiology.
8) Excellent verbal and written communication skills.
9) Assist in writing deviations, investigations, change control and OOS as required.
Education and Skills required:
Education: Four-year college degree in Microbiology or related science is required.
Experience: Must have at least two to three years work experience in GLP/GMP FDA regulated environment.
Interacts With:
1) Vendors for supply acquisition.
2) Clients during site visits in regard to microbiology matters.
3) Manufacturing and Quality departments.
Please send your cover letter and attached resume to: click here
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