Scientist I - Emeryville, United States - 4D Molecular Therapeutics

4D Molecular Therapeutics Emeryville, United States

1 month ago

Full time

Description

Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your ability to work with 4DMT in the future.

4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products. We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases.

We have built a deep portfolio of AVV-based gene therapy product candidates, with five product candidates in clinical trials: 4D-150 for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), 4D-710 for the treatment of cystic fibrosis lung disease, 4D-310 for the treatment of Fabry disease cardiomyopathy, 4D-125 for the treatment of X-linked retinitis pigmentosa (XLRP), and 4D-110 for the treatment of choroideremia. In addition, we have two product candidates in preclinical studies: 4D-175 for geographic atrophy (GA) and 4D-725 for alpha-1 antitrypsin deficiency.

To-date, we have demonstrated clinical proof-of-concept for three evolved vectors in three therapeutic areas and routes of administration with five products and patient populations. We believe this validates the power of our directed evolution platform for discovering superior vectors compared to wildtype viral vectors. We have built a robust and efficient product engine with 6 open Investigational New Drug Applications (INDs) in the U.S., 1 IND in Taiwan, and 1 Clinical Trial Approval (CTA) in Australia. We believe we are positioned to create, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines that could transform the lives of patients suffering from debilitating diseases.

In addition to TVE, our technology includes a robust AAV manufacturing platform and onsite manufacturing facility that allows us to rapidly produce and test research grade material and scale up to GMP clinical material. This internal capability and close collaboration between our R&D and Manufacturing teams has greatly accelerated the pace of discovery at 4DMT.

Company Differentiators:

• Fully integrated clinical-phase company with internal manufacturing

• Demonstrated ability to move rapidly from idea to IND

• Five candidate products in the clinic and two declared pre-clinical programs

• Robust technology and IP foundation, including our TVE and manufacturing platforms

• Initial product safety and efficacy data substantiates the value of our platforms

• Opportunities to expand to other indications and modalities within genetic medicine

We are a high-performing, innovative, team-based organization, where collaboration, flexibility, initiative, energy, and motivation is essential. Reporting to the Senior Manager of ADQC, the primary role of the Scientist I in Analytical Development/Quality Control (ADQC) is to provide support to clinical programs by providing quality testing and delivering results in accordance with cGMP standards. Ensuring our products are safe for patients and fit for purpose.

The Scientist I in Analytical Development/Quality Control (ADQC) (QC focus) is responsible for authoring technical reports and protocols, performing routine analytical testing, data analysis, method qualification and method validation. The candidate will work closely with Process Development, Manufacturing, and Quality organizations to support raw material, in-process, release, and stability testing onsite. The successful candidate will be experienced with analytical techniques including but not limited to qPCR/ddPCR, AUC, Biolayer Interferometry (BLI), electrophoresis, ELISA, CE (CE-SDS, cIEF), and UV/Vis spectroscopy. The successful candidate with have working knowledge of cGMP testing regulations.

*Seeking Bay Area based candidates. GMP laboratory experience in the pharmaceutical industry required*

RESPONSIBILITIES:

Routine Sample Testing and Data Analysis: 30% of TIME

Perform testing of raw material, in-process, release, and stability samples under cGMP

Maintain accurate and well-organized laboratory records

Perform primary review of QC raw data and trend results

Draft technical reports using statistical analysis

Review and present analytical data to cross-functional teams

Author QC SOPs and complete change control

Support the authoring and review of CMC sections of INDs

Identify gaps and mitigate impact when industry guidelines or pharmacopeia sections are updated

Train colleagues in areas of expertise

Perform testing in support of process development

Evaluate results against defined acceptance criteria

Method Qualification and Validation: 40% of TIME

Implementation of phase-appropriate test methods and specifications.

Identify trends that drive method requirements and ensure methods are fit for purpose

Provide technical guidance as subject matter expert to QC staff

Transfer, optimize and trouble-shoot analytical methods for use in Quality Control

Draft analytical method Standard Operating Procedures

Draft protocols and reports in support of analytical method qualifications.

Execute testing in support of analytical method qualification and validation.

Quality System Oversight: 30% of TIME

Maintain a cGMP compliant testing laboratory

Perform equipment PMs, and manage equipment calibration documentation

Support implementation of new Laboratory Information Management System (LIMS)

Author technical documents for reference material qualification studies

Lead laboratory investigations

Other duties as assigned, nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

QUALIFICATIONS:
Education:

Ph.D. in a relevant scientific field; MS Degree or Bachelor of Sciences degree in a technical discipline (Biochemistry, Biology, or related field) is required.

Experience:

8+ years of relevant hands on GMP laboratory experience in the pharmaceutical industry.

Strong background in assay qualification/validation under ICH Guidelines.

Knowledge of viral gene therapy (adeno associated viral vectors) preferred.

Ability to work independently and work with others in designing and developing experiments, analyzing, and interpreting data in a rigorous way.

Ability to multi-task and support more than one project simultaneously.

Understanding and knowledge of key scientific software programs (SoftMax, QuantaSoft, etc.)

Understanding and knowledge of regulatory requirements for biologic products and cGMPs.

Strong organizational, analytical, and problem-solving skills.

Strong communication skills both written and oral with demonstrated ability to present ideas and information and data effectively via one-on-one discussions, team meetings and partnership interactions.

Experience with CMC activities for clinical programs.

Strong regulatory and GMP acumen.

Skills:

Sound understanding of scientific principles.

General understanding of compendial testing, ICH qualification/validation.

Strong verbal and written communication skills and effective interpersonal, technical discretion and troubleshooting skills are essential.

Must be a team player, strong critical thinker, exhibit a willingness to meet project timelines and multitask effectively in a dynamic fast-paced environment under challenging timelines.

Proficient or familiar with Microsoft based Windows programs: Word, Excel and PowerPoint.

BASE SALARY COMPENSATION RANGE:
Bay Area-based candidates: $128,000/yr. - $149,000/yr.
4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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