OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a BioProcess Engineer in Long Island, New York. The BioProcess Engineer role will develop and scale up internal manufacturing processes to support the growth and advancement of the client's regenerative medicine products. If you are a career-focused professional, this is the role for you.

RESPONSIBILITIES

• Contribute to late stage process development for transferring new products and processes to manufacturing
• Select appropriate components and equipment based on analysis of specifications reliability and regulatory requirements for aseptic manufacturing
• Identify, implement, and develop equipment to support scale up of internal manufacturing of intermediates
• Analyze equipment to establish operating data, conduct experimental test, and analyze results
• Ensure that all activities are completed, documented in accordance with procedures, and investigations are supported
• Assist in resolving technical issues with equipment and production processes
• Participate in PFMEA and other process risk-based process evaluations
• Design and execute equipment/process qualifications and validation studies
• Implement new processes and products
• Draft equipment/materials specification, operating SOPs, work instructions, and provide training for manufacturing team members
• Verify quality of process and product as defined in the appropriate equipment operation and material specifications
• Support development of relevant manufacturing metrics, data collection, reporting, process improvements, and regulatory CMC documentation
• Collaborate with the Quality organizations to help investigate any excursions, deviations, CAPAs, and develop appropriate corrections

EXPERIENCE

• Minimum of 5 years of experience in biopharmaceutical manufacturing engineering/development required
• Knowledge of FDA, GMP, and ICH requirements
• Demonstrated experience improving quality and scaling up/out manufacturing processes and systems to support biopharmaceutical development
• Experience developing aseptic cell culture processes (adherent or suspension)
• Experience with process development for Biologics, cell-based therapies, and/or Advanced Technology Medicinal Products preferred
• Strong communication skills with the ability to effectively work cross-functionally and externally
• Excellent strategic thinking and influencing skills

EDUCATION

• Minimum of Bachelor's Degree in biomedical engineering, chemical engineering, or similar related field required

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.