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STUDENT ASSISTANT

Chino, CA · On-site

$16.25 - $20.50/hr

... therapeutic recreation programs for patients within California Department of Corrections and ... GC) Section 18220 are encouraged to apply and will be given priority. If you are applying under ...

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Gc Therapeutics information

What is GC Therapeutics?

GC Therapeutics refers to professionals or organizations specializing in gene and cell (GC) therapy. These experts develop, test, and manufacture advanced therapies that use genetic engineering or cellular manipulation to treat a range of diseases, including genetic disorders and cancers. GC Therapeutics may involve roles in research, clinical trials, regulatory affairs, and biomanufacturing. Their work is critical for advancing innovative treatments that go beyond traditional pharmaceuticals. The field is rapidly growing and requires a strong background in biology, biotechnology, and regulatory compliance.

What are common challenges faced by professionals working at GC Therapeutics, and how can they be addressed?

Professionals in GC Therapeutics often encounter challenges such as staying current with rapidly evolving gene and cell therapy technologies, navigating complex regulatory requirements, and coordinating multidisciplinary teams. To address these, it's important to engage in continuous professional development, maintain open communication across research, clinical, and regulatory departments, and participate in industry forums or workshops. Collaboration and adaptability are key, as projects frequently require input from scientists, clinicians, and regulatory experts to ensure successful therapeutic development.

What skills and qualifications are needed to thrive as a Cell Therapy Scientist at GC Therapeutics?

To thrive as a Cell Therapy Scientist at GC Therapeutics, you need a strong background in cell biology, molecular biology, or a related field, typically supported by an advanced degree (MS or PhD) and relevant laboratory experience. Familiarity with cell culture techniques, flow cytometry, gene editing tools like CRISPR, and regulatory compliance systems such as GMP is essential. Strong analytical thinking, attention to detail, and effective teamwork and communication skills distinguish top performers in this role. These competencies ensure the safe, efficient, and innovative development of cell-based therapies for clinical applications.

What is the difference between Gc Therapeutics vs Clinical Research Associate?

AspectGc TherapeuticsClinical Research Associate
Required CredentialsBachelor's degree in life sciences, relevant certificationsBachelor's degree, often with clinical research certifications
Work EnvironmentPharmaceutical or biotech company, laboratory settingClinical trial sites, hospitals, research organizations
Employer & IndustryBiotech firms, pharmaceutical companiesResearch organizations, CROs, pharmaceutical companies
Common Search & ComparisonYesYes

Gc Therapeutics professionals focus on developing and testing new therapies within biotech or pharmaceutical companies, often working in labs. Clinical Research Associates (CRAs) oversee clinical trials at research sites, ensuring compliance and data accuracy. While both roles require scientific backgrounds and industry experience, Gc Therapeutics roles are more research and development-oriented, whereas CRAs are more involved in trial management and site coordination.

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Gc Therapeutics jobs near you
Infographic showing various Gc Therapeutics job openings in the United States as of August 2026, with employment types broken down into 77% Full Time, 6% Part Time, and 17% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution.

Senior Director, Analytical Research & Development

Seaport Therapeutics

Boston, MA • On-site

Full-time

Re-posted 1 hour ago

Job description

Seaport Therapeutics is a clinical-stage therapeutics company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph™ technology platform. All the therapeutic candidates in its pipeline of first and best-in-class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first-pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that invented and advanced important neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders. For more information, please visit www.seaporttx.com.
Seaport Therapeutics is seeking someone to lead analytical research and development for its portfolio of small molecule programs targeting neuropsychiatric disorders. The Senior Director, Analytical R&D, reports to the Vice President, CMC and is responsible for providing strategic and technical leadership for analytical development of small molecules within Seaport's portfolio, from pre-clinical development to late-stage clinical development. This includes oversight of analytical method development, validation, method transfer to CMO's, and support of regulatory filings, including investigational new drugs (INDs)/investigational medicinal product dossier (IMPDs) and new drug applications (NDAs). The role also includes strategic partnering with Quality, Development & Manufacturing, and Regulatory to deliver uninterrupted clinical supplies to enable Seaport's current and future clinical studies.
The role will be accountable for delivering analytical methods that are phase-appropriate and adhere to the highest scientific standards. The successful candidate must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, in addition to several years' experience overseeing analytical development at CMO's.
The position is responsible for ensuring that all method development, validation and testing (release, stability, and other) performed on behalf of Seaport is conducted in accordance with the appropriate compendial standards, when available, and is compliant to all regulations and industry phase-appropriate testing standards and standard operating procedures. The Senior Director will also ensure that all testing and testing services coordinate with all other product development activities so that testing does not fall on the critical path and causes product development delays.
The ideal candidate will embrace a collaborative, innovative culture that embodies our values of service to patients impacted by mental health conditions, with a "we own it" mentality, demonstrating entrepreneurial spirit and technical excellence while fostering teamwork and continuous improvement. This position is based in Boston's Seaport area, with a strong preference for being onsite 4 days per week.
Key Responsibilities:
  • Serve as the functional head of Analytical Research & Development, accountable for analytical strategy across Seaport's small-molecule portfolio from preclinical through late-stage clinical development.
  • Define and implement phase-appropriate analytical development strategies for drug substance (DS) and drug product (DP), aligned with overall CMC and regulatory objectives.
  • Lead and develop the Analytical function within CMC, including direct management of analytical staff and thoughtful planning for future capability needs as the portfolio advances.
  • Establish best practices for analytical lifecycle management, data integrity, documentation, and knowledge transfer.
  • Define and execute Seaport's outsourced analytical strategy, including selection, onboarding, governance, and performance management of CDMOs and contract testing laboratories.
  • Provide strategic oversight and day-to-day governance of CDMO's, ensuring adherence to scope, timelines, quality standards, and data integrity expectations.
  • Provide technical leadership for analytical method development, validation, and transfer for DS and DP, utilizing techniques including (but not limited to) HPLC-CAD, HPLC-UV, GC, LC-MS, LC-MS/MS, HPLC-FLR, LC-qToF, GC (Residual Solvents), Elemental impurity analysis, IR, qNMR, thermal analysis, droplet size, PSD, lipolysis, and dissolution/ drug release.
  • Ensure analytical methods and specifications are scientifically justified, phase-appropriate, and compliant with applicable compendial standards and regulatory guidelines.
  • Review and approve analytical methods, validation protocols, analytical reports, stability protocols, and stability test reports.
  • Oversee stability programs, including trending and proactive identification of potential quality or stability issues.
  • Collaborate closely with QA, Regulatory Affairs, Development & Manufacturing, Clinical Supply, and Research to ensure alignment across development activities.
  • Ensure analytical activities are integrated into overall project plans and do not become a critical path for development timelines.
  • Provide analytical CMC leadership for regulatory filings, including INDs, IMPDs, NDAs, and MAAs, with direct responsibility for authoring and reviewing analytical sections.
  • Partner with Quality Assurance to support audits of external testing facilities and contribute to Quality and Service Agreements.

Professional Experience/Qualifications:
  • MS or Ph.D. in Analytical Chemistry, Physical Chemistry, or a related scientific discipline.
  • 12-15+ years of progressive industry experience in small-molecule analytical development within pharmaceutical or biotechnology organizations.
  • Demonstrated experience leading analytical development across multiple development stages, including late-stage clinical development and registration-enabling activities.
  • Proven experience serving as a functional or sub-functional leader, including people leadership and accountability for analytical strategy execution.
  • Extensive hands-on expertise in chromatographic and spectroscopic techniques, including GC, LC, IC, chiral separations, and detection methods such as UV/Vis, CAD, MS (SIM/MRM), fluorescence, FID, and ECD.
  • Experience managing analytical development and testing activities through CDMOs and contract laboratories in a virtual or highly outsourced operating model.
  • Strong knowledge of global regulatory requirements and ICH guidelines applicable to analytical development and control strategies.
  • Experience with complex lipophilic drug substances and formulations, including enabling formulation approaches (e.g., SEDDS, soft-gel dosage forms).
  • Demonstrated ability to lead and influence cross-functional teams in a fast-paced, resource-constrained biotech environment.
  • Excellent communication, collaboration, and scientific judgment skills, with the ability to make sound decisions balancing speed, quality, and regulatory expectations.
  • Willingness to travel internationally approximately 25% of the time.

At Seaport, we believe transparency and fairness are key to building a culture of trust, respect, and collaboration. We care deeply about the happiness of our team and strive to ensure our total rewards (monetary and non-monetary) program reflects the value each person brings. The expected salary range for this role is $230,000-$270,000, with the final offer based on experience, market data, and internal equity. We encourage open conversations with our talent acquisition team about compensation early in the process to ensure alignment from the start.

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