A New Beginning-Genesis Hiring for Bioanalytical Ligand Binding Assays skills req, preference given to people Job at Remote Full Time

People from outside North America, we cannot help you, sorry.

YOU MUST HAVE EXTENSIVE PAID INDUSTRY EXPERIENCE IN THE USA FOR THESE JOBs

The ideal person is willing to reside AND be on site in Marin County California, or NJ or MD

Please call 860 889 4141 til 8PM EST 7 days a week after you email a word doc resume

Thank you

Joe V

1-Senior Scientist, Bioanalytical Sciences (PK/PD) Ligand Binding Assays for PK and ADA SFC

2-Scientist (PCR and Molecular Biology) Ligand-binding assays (e.g. ELISA / MSD) Ideally with experience in development of PCR assays NJ

3-Experienced Bioanalytical CRO Project Manager (Principal Investigator / Scientist) Ligand-binding assays (e.g. ELISA / MSD) Ideally with experience in development of PCR assays MD

Please read the complete job descriptions

1-Senior Scientist, Bioanalytical Sciences (PK/PD) Ligand Binding Assays for PK and ADA SFC

2-Scientist (PCR and Molecular Biology) Ligand-binding assays (e.g. ELISA / MSD) Ideally with experience in development of PCR assays West Trenton, NJ 08628,

3-Experienced Bioanalytical CRO Project Manager (Principal Investigator / Scientist) Ligand-binding assays (e.g. ELISA / MSD) Ideally with experience in development of PCR assays Gaithersburg, MD 20878

1-Senior Scientist, Bioanalytical Sciences (PK/PD)

Experience developing Ligand Binding Assays for PK and ADA is a must.

7+ to 10 years experience

Seniority Level – Mid-Senior

Minimum Education – Bachelor’s Degree

Willingness to Travel – Never

Ideal Candidate
A minimum of a Bachelor’s degree in a scientific discipline with 9+ years of work experience, Master’s degree with 7+ years or Ph.D. with 3+ years of work experience. Equivalent experience may be accepted.

GLP/GCP is desirable.

Mammalian cell culture experience is desirable.

The company is seeking a detail-oriented and highly motivated Senior Scientist to join the Bioanalytical Sciences team. The successful candidate will be responsible for developing, qualifying, and transferring immunoassays (e.g., ELISA, ECLIA on MSD platform) and/or Cell-Based Assays to support pharmacokinetic (PK) and immunogenicity (ADA) readouts from in vivo studies to help advance research, pre-clinical, and clinical stage programs. The incumbent will also analyze pre-clinical study samples using immunoassays, Luminex, and/or cell-based assays. This list contains the major duties and requirements of the job and is not all-inclusive. The selected individual may be expected to perform role-related duties other than those contained in this document.

ESSENTIAL FUNCTIONS:

Develop, qualify, and transfer complex ligand binding assays for measuring the PK of XTENylated molecules and relevant metabolites, and for detection of antibodies against XTENylated molecules.

Interact with CRO vendor partners to oversee PK and ADA method transfer, validation, and regulated sample analysis in support of GLP Tox and Clinical studies.

Perform Non-GLP pre-clinical sample analysis using in-house qualified assays (PK, PD, ADA).

Document all activities in an electronic notebook, compile data and analyze results in a timely fashion.

Present data in group settings to update other teams on progress of assay development.

Perform routine equipment maintenance, calibrations, and verifications as needed.

Collaborate with other assay development team members to complete tasks and meet departmental goals.

Work cross-functionally with members of other departments to complete tasks when required.

BASIC QUALIFICATIONS:

A minimum of a bachelor’s degree in a scientific discipline with 9+ years of work experience, Master’s degree with 7+ years or Ph.D. with 3+ years of work experience. Equivalent experience may be accepted.

Experience developing Ligand Binding Assays for PK and ADA is a must.

Proficient in working with Microsoft Word, Excel, and PowerPoint.

Ability to work in a fast-paced, dynamic environment with effective time-management skills.

Must be willing to work as part of a team and demonstrate good interpersonal skills.

Self-motivated to carry out both new and routine tasks.

PREFERRED QUALIFICATIONS:

Experience working in a GCP/GLP environment is desirable.

Mammalian cell culture experience is desirable.

Experience with electronic notebook systems, SoftMax Pro, and Prism a plus.

Base Salary – USD $140,000 to $150,000

2-Scientist (PCR and Molecular Biology) Ideally with experience in development of PCR assays

We assists in the development of new medicines by providing bioanalytical services for all phases of drug development from discovery through approval and post market surveillance. We work with customers to develop new methods, validate existing methods, and perform the assays necessary to analyze samples from patients on more than 100 clinical trials. We are seeking a Scientist with experience in Molecular Biology to join our team. The successful candidate is able to apply prior experience and knowledge to successfully perform in a laboratory environment under regulated conditions.

Essential Position Responsibilities:

Proficiently perform Molecular biology techniques such as purification of nucleic acids and quantitation assays (e.g. qPCR or ddPCR)

Proficiently performs Cell biology techniques applying acceptable aseptic technique.

Able to qualify and proficiently perform Ligand-binding assays (e.g. ELISA / MSD) applicable to Pharmacokinetic, Biomarker and Immunogenicity studies is a plus.

Independently performs service tasks as directed.

Independently performs analysis for validation and sample testing in support of GLP studies.

Assists with method transfer, development, and troubleshooting in support of GLP studies.

Responsible for data interpretation and provide data summaries for studies.

Performs study activities to meet the regulatory, GLP, protocol, and SOP requirements.

Maintains the experimental records and raw data in a secure way to protect the integrity of the data.

Reviews and checks data generated by other staff as assigned.

May represent group in cross departmental initiatives.

Works safely with potentially hazardous substances, exercise universal precautions.

Functions effectively in a team-oriented atmosphere and work independently when necessary.

Knowledge of Watson LIMS and cell culture techniques a plus.

Capable of navigating and updating electronic inventory systems.

Maintains a clean lab and work environment.

Perform other duties as assigned.

Additional Position Requirements:

May perform operational duties in areas of appropriate experience and training.

Mentoring and training junior staff

Become a Subject Matter Expert on process or equipment

Must be able to lift 40 pounds.

Additional Requirements:

Perform general laboratory support functions such as supply inventory, shipping procedures, or data maintenance.

Ability to multi-task and produce quality analysis while working under the pressure of strict deadlines.

Overtime, weekend and holiday work as required.

Effective written and oral communication skills.

Work requires some standing and sitting for long periods of time, including working within a laboratory hood and at standing bench top.

Repetitive work with hands.

Qualifications:

BA/BS in Biological or Physical Sciences and at least 2 – 3 years of relevant experience, MS in relevant field and at least 1-2 years of relevant experience.

Level of position will be commensurate with experience.

Knowledge of GLP regulations and other regulatory guidelines.

Excellent communication skills, both oral and written, and strong organizational skills.

Proficient in the use of basic computer applications such as MS Word and Excel.

lims AND glp AND Ligand AND Binding AND (Assay OR assays) AND pcr AND (ELISA OR MSD

3-Experienced Bioanalytical CRO Project Manager (Principal Investigator / Scientist) Ideally with experience in development of PCR assays

We offer contract research services for large molecule bioanalysis, assay development, validation, and sample analysis. The Project Manager is responsible for being the client’s primary point of contact and for the overall conduct of the study.

The Project Manager ensures client deliverables are met on-time, within scope, and within established quality standards. This position regularly interacts with clients for current studies and potential future studies awarded.

Essential Position Responsibilities:

Responsible for client interaction and the conduct of studies.

Responsible for data interpretation, analysis, and reporting of results for bioanalytical method development and validation.

Responsible for the management of preclinical and clinical sample analysis using bioanalytical methods.

Maintains and applies experience and knowledge of ligand-binding assays (e.g. ELISA / MSD) applicable to Pharmacokinetic, Biomarker and Immunogenicity studies to support existing and new client studies.

Integrates bioanalytical contract research organization (CRO) business objectives in daily activities.

Maintains knowledge and applies regulatory and GLP requirements, FDA guidelines, and industry standards for bioanalytical method validation and sample analysis.

May mentor, train, or supervise new or less experienced team members.

Participates in or contributes to business initiatives, such as process improvement, quality, culture, etc.

May perform operational duties in areas of appropriate experience and training.

Corporate Responsibilities:

Adherence to laboratory health and safety procedures.

Adherence to Standard Operating Procedures (SOPs) & applicable company policies/ guidelines.

Adherence to federal and/or local regulations, as applicable.

Minimum Qualifications:

B.S. / B.A. degree in Biology or related field and a minimum of 10 years of relevant experience in the CRO industry; or, advanced degree in Biology or related field and at least 5 years of relevant experience in the CRO industry.

Knowledge of GLP regulations and regulatory guidelines.

Excellent communication skills, both oral and written.

Strong leadership and organizational skills.

Excellent organizational skills.

Proficient in the use of basic computer applications such as MS Word and Excel.

Ability to multi-task and produce quality analysis while working under the pressure of strict deadlines.

Proficient in time management and resource planning.

Ability to initiate and implement self-development efforts.

Knowledge of Watson LIMS preferred.

Ability to effectively interact at all levels of the organization in addition to with clients and regulatory personnel

Ability to make decisions and complete assignments with minimal guidance.

Ability to establish work priorities and manage shifting priorities.

Job Type: Full-time

Pay: $85,000.00 – $155,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Relocation assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

Supplemental pay types:

• Bonus pay
• Signing bonus

Experience:

• Ligand Binding Assay: 2 years (Required)

Work Location: Remote