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Tech Transfer Specialist, Operations

Location: 

Baltimore (Camden), MD, US, 21230


 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

I.    JOB SUMMARY 
The candidate will support process validation and process transfer activities as a member of the Technical Transfer Process (TTP) Team which is a part of the Manufacturing Science & Technology (MS&T) Department supporting the contract manufacturing business unit. 

Individual working at this position will function as the overall technical subject matter expert (SME) for the development and tech transfer of new products and processes into CGMP Production, specifically as related to formulation, sterile filtration and sterile filling of pharmaceutical and biological drug products at the facility. 

 

The individual performs research and/or development roles in collaboration with others, on new products/formulations or processes, and in modifications to existing products or processes. The individual collaborates with the team to set developmental study objectives and executes the studies in a leading role. The role requires strong knowledge of process development and process validation including analytical techniques, statistical sampling, as well as critical parameter assessment and control strategy development. The individual is responsible for leading various departmental projects taking into account scientific knowledge and timing objectives.

 

Responsibilities include designing experiments/studies, authoring protocols (e.g., engineering runs; process performance qualifications), reviewing and analyzing complex data, and authoring process validation protocols and reports. Support the development of manufacturing production records.

Experience with fill/finish operations, aseptic and/or isolator manufacturing, process validation/process performance qualifications, and technical writing are recommended. Candidate must have technical evaluation skills and also have excellent communication skills, both written and verbal. 

 

II.    ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
•    Assist in the development of clinical and commercial drug products manufacturing methods especially related to on-the-floor GMP requirements, operating parameter identification, and formulation activities.
•    Work with MS&T team members and experts from other departments to develop studies 
•    for process development, process optimization, scale-up, manufacturing records and technology transfer. Studies will include evaluating the robustness of the manufacturing process and that will serve as a baseline for the further process validation activities. The individual will design and oversee study execution.
•    Solid understanding of protein structure and protein formulations including the scientific basis for the use of buffers, pH adjustments and methods for controlling oxygen exposure and temperature related-changes. Individual has a good understanding of related analytical techniques such as HPLC, traditional concentration assays, etc. which are utilized to evaluate product quality.
•    Evaluate process data and perform in-depth analysis using scientific principles for evaluation of critical process parameters governing the performance of the process. Exercises judgement in selecting methods, techniques and evaluation criteria. Independently review and analyze process data from the clinical and commercial manufacturing batches for conformity and facilitate batch release.
•    Represents MS&T department as subject matter expert routinely in meetings/conference calls with clients.
•    Work with client’s lead technical staff, department management and senior management to evaluate technical details pertaining to projects. 
•    Function as the Subject Matter Expert (SME) for Manufacturing processes and Technical Transfer of new products regarding process development.
•    Collaborate with analytical, production, quality and project management team and ensure timely completion of project deliverables.
•    Independently work with multiple cross-functional projects that may require regulatory submissions.
•    Effectively present complex technical information to guide decision making.
•    Author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
•    Provide technical support for fill finish manufacturing activities including OOS/OOT investigation, process deviation impact, root cause investigation, process change and optimization.
•    Perform periodic review of processes/systems.
•    Write and revise SOPs and Master Plans.
•    Apply CGMP and CGDP to all areas of work.
•    Support the development of manufacturing production records and protocols in for qualifications, developmental/technical transfer projects, or for clinical and commercial manufacturing
•    Provide training to managers and production/laboratory staff for protocol requirements and new manufacturing processes. 
•    Work with individuals at all education/experience levels and with multiple departments (production, laboratory, engineering, materials management, etc.). 

 

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
BS in Chemistry, Science or Engineering related science and minimum of 5 years of equivalent job experience in sterile injectable pharmaceutical manufacturing. At least 3 years experience in development or tech transfer role.

 

•    High level of personal/departmental accountability and responsibility.
•    Understanding of process design principles.
•    Experience with drug product manufacturing, processes development, process scale-up or optimization preferred
•    Ability to perform well under tight timelines and excellent decision-making quality under pressure is desired.
•    Ability to manage multiple priorities and tasks in a dynamic environment.
•    Excellent written and verbal communication skills 
•    Data evaluation and interpretation. Some statistics and process controls experience recommended.
•    Ability to exercise judgment to determine appropriate corrective actions.
•    Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
•    Ability to work in a team environment with multiple departments and experience/ educational levels.
•    Working knowledge of CGMP. 
•    Coordinate multiple tasks simultaneously.
•    Manufacturing background in pharmaceutical development/research is a plus. 
•    Previous exposure to sterile processing principles (aseptic or isolator technology) preferred. 
•    Understanding of pharmaceutical development/research and regulatory compliance is a plus.
•    The role must demonstrate solid cross-departmental communication, organization and planning.
 

 

Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Baltimore