We are currently searching for a skilled professional to join a well-known client's team as a Senior Scientist, Analytical QC Development in Gaithersburg, Maryland. This Senior Scientist role will develop and conduct assays on in process, drug substance, and drug product release testings. If you are a career-focused professional, this is the role for you.
Develop and characterize for the siRNA pipeline products
Analyze and interpret results
Plan future experiments based on findings to advance understanding of the product candidates and method development
Generate and review SOPs, test records, and protocols for testing of RNA therapeutic products (internally and externally)
Write/review analytical method protocols/stability protocols for siRNA products to meet clinical needs
Characterize biophysical and physiochemical properties of siRNA therapeutics
Prepare technical reports and presentations for clear communications across interdisciplinary teams
Serve as liaison when time comes to transfer the technology to other internal production site(s) and external CDMOs
Conduct technical reviews of batch records for lot release and CDMO summary reports
Minimum of 8 years of relevant experience in method development required
Demonstrated experience with cell culture, PCR, biochemical, and immunological assays
Success in the development of assays to characterize therapeutic products
Experience in analytics (QC methods, assay development, tech transfer, etc.)
Strong written and verbal communication skills
Proficient in Microsoft office applications (Word, Excel, PowerPoint, etc.)
Experience with siRNA or nucleotide-based method development and method development of nanoparticles preferred
Knowledge of Quality systems, GMP requirements, and ICH guidelines desired
Minimum of Advanced Degree (MS/PhD, or equivalent) in or equivalent experience in Chemistry, Biological Science, Biochemistry, Biochemical, Biomedical Engineering, or a 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 and 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 and 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.