We are currently searching for a skilled professional to join a well-known client's team as a Senior Process Engineer in Cambridge, Massachusetts. The Senior Process Engineer role will support AAV clinical scale process development and technical transfer in the Technical Operations organization. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
Manage HEK293 stir tank bioreactor process development and transfection optimization
Develop and perform pre-clinical scale up production processes based on QbD
Create SOPs, establish critical process parameters, and lead technology transfers to CROs/strategic partners
Provide expertise and guidance in clinical AAV production, development, and innovation across the organization
Communicate development results and production schedules with internal teams
Operate and maintain bioreactors and multiple laboratory instruments
Maintain and analyze cell culture
EXPERIENCE
Minimum of 8 years of hands on industrial experience required, minimum of 6 years considered with Master's Degree
Experience with HEK suspension, AAV production, and characterization
Proficient with operation/process optimization in stir tank bioreactors and relevant cell culture analytical techniques
Experience in bioreactor cell culture and purification process development scale up for GMP production
Strong coordination, organizational, and problem-solving skills
Experience with viral vector analysis (e.g. CE-SDS, ddPCR, ELISA) desired
Excellent verbal and written communication skills
EDUCATION
Minimum of Bachelor's Degree in Biochemical Engineering, Molecular Biology, or Virology required
Master's Degree preferred
To be a best-fit your strengths must include:
Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
