Senior Biopharmaceutical Engineer

2 weeks ago

Frederick, Maryland, United States Diaconia LLC Full time

Join Diaconia LLC as a Senior Biopharmaceutical Engineer

At Diaconia, we value our employees and their unique skills. We are dedicated to fostering a supportive environment for our team members, clients, and the wider community. Our workforce is composed of skilled professionals who thrive on collaboration and innovation, aiming to make a meaningful impact in the industry.

We are currently seeking a full-time addition to our team for the role of:

Senior Biopharmaceutical Engineer

We are in search of a highly skilled Senior Biopharmaceutical Engineer to assist our organization in the advancement and acquisition of medical products and systems aimed at biodefense. The ideal candidate will possess a robust background in pharmaceutical and biotechnology advanced development, with a focus on program management, product innovation, and FDA regulatory processes aligned with Department of Defense (DoD) acquisition standards.

U.S. CITIZENSHIP REQUIRED

Key Responsibilities:

  • Showcase a proven history of securing patents or contributing to publications in reputable scientific journals.
  • Demonstrate expertise in program management, product innovation, contractual guidance, and advisory roles.
  • Participate in technical discussions with peers and contribute to strategic initiatives.
  • Utilize Microsoft Office applications proficiently, including Outlook, Project, PowerPoint, Excel, and Word.
  • Ensure alignment of FDA regulatory processes with DoD acquisition protocols for the development and procurement of medical products and systems for biodefense.
  • Possess experience in the design, installation, commissioning, and validation of Single-Use Systems (SUSs).
  • Exhibit familiarity and expertise with biologics Current Good Manufacturing Practices (GMP), including quality assurance, quality control, and biologics license application preparation.
  • Demonstrate proficiency in current good laboratory practices, FDA Animal Rule requirements, and FDA submission processes for Investigational New Drug (IND) and New Drug Application (NDA) approvals.

Disclaimer: The responsibilities and duties outlined in this job description are intended to describe the general nature and level of work performed by employees within this role. However, they are not exhaustive and may be subject to change or modification at any time to meet the evolving needs of the organization.

Minimum Qualifications:

  • Hold a PhD or master's degree in engineering, physics, chemistry, biology, engineering management, or related fields.
  • Possess a minimum of 10-15 years of relevant industry experience, particularly in pharmaceutical/biotechnology advanced development from IND to FDA approval.
  • Have a strong understanding of FDA processes and DoD acquisition requirements.
  • Experience with the design and validation of Single-Use Systems (SUSs).
  • Knowledge of biologics Current Good Manufacturing Practices (GMP).
  • Expertise in FDA submission processes for IND and NDA approvals.

Preference may be given to candidates residing in a Hubzone Area, as defined by the United States Small Business Administration (SBA) program for small businesses operating in Historically Underutilized Business Zones (Hubzone).

Selected applicants will undergo a government security investigation and must meet eligibility requirements for access to classified information. Diaconia LLC is an Equal Opportunity Employer, welcoming applicants from diverse backgrounds including minorities, females, veterans, and individuals with disabilities. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

Candidates must be willing to consent to a background check, including a criminal record check, employment verification, and education verification. No exceptions will be made.

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