736 Bioinformatics Scientist jobs in Sayreville,NJ

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Associate Director, Biostatistics

Genmab

Plainsboro, NJ 08536

RemoteEducation AssistanceHealth InsurancePaid Time OffRetirement Benefit

Master's or PhD in a statistical discipline
8+ years of experience in relevant area preferred, or demonstrated capability
Experience in statistical analysis, modelling and simulation and adaptive trial designs
Experience with drug development in biologics, targeted therapies, and companion diagnostics preferred
Experience working with FDA, EMA, and ICH guidance for drug development pertaining to statistics
Experience with the relevant regulatory requirements for biostatistics processes and SOPs
Experience with regulatory submissions including BLAs and previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies
Experience working with SDTM, ADaM, eSUB, and CDISC requirements for regulatory submissions
Experience directing multiple complex projects/studies in a technical capacity
Proven performance in earlier role/comparable role

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Biochemist

United States Army

New York, NY 10025

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Head of Biologics Development & CMC

Neion Bio

New York, NY 10065

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Microbiologist

United States Army

Elizabeth, NJ 07202

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Environmental Health and Safety - Senior Manager

Kashiv BioSciences LLC

Piscataway, NJ 08854

~ 28 min Onsite

Bachelor's Degree in Safety, Environmental Health, Industrial Hygiene, or a related field (or equivalent experience)
10+ years of EHS experience within a manufacturing environment in Pharma/Biopharma
Strong knowledge of OSHA regulations and safety compliance programs
OSHA industry training
Experience leading safety training, audits, and incident investigations
Experience working in regulated manufacturing environments (such as FDA or cGMP-regulated industries) preferred
Experience supporting fast-paced production environments utilizing automated equipment or packaging systems preferred
Ability to work cross-functionally and influence safety initiatives across departments
Strong communication and collaboration skills with the ability to act as a change agent within operations
Hazardous shipping guidelines
Knowledge of MSDS
Direct experience with regulated environments (e.g., cGMP, OSHA, EPA) preferred
Experience of working in a highly regulated environment would be a significant advantage
Remains calm under pressure, displaying a positive, solution driven approach.
Displays key leadership skills, being visible, approachable, and accountable.
Understands Kashiv's commitments and delivers with passion and urgency.
Act with honesty, integrity and respect for people and goals.
Can prioritize activities and own workload, ensuring vital tasks are recognized and acted upon.
Has Subject Matter Expertise in relevant EHS regulations, principles, pollution control technology, industrial hygiene and safety-related equipment & safeguards. Has basic technical knowledge and works on practical, worker health, safety and environmental problems.
Can effectively interact with team members. Can articulate the issues and solutions to teams upon which participates.
Can identify EHS technical problems, analyze effectively and solve in consultation with supervisor. Learns to develop investigation and problem-solving skills using standard safety engineering and technology techniques.
Can develop, analyze and interpret data.
Can collaborate with others to determine areas of potential risk to business success and generate gap analysis.
Skill to document technical assignments expeditiously.
Capable to work on multiple small projects simultaneously and meet deadlines.
Self-starter to manage workload and meet deadlines set by upper management. Gathers experience in planning work product deliverables to team projects to assure projects stays on track.
Learns application of basic safety engineering and science skills in product or process evaluation under supervisor.
Ability to work with contractors and provide support to others who review/approve and manage external EHS services in meeting business initiatives.
Maintains gowning certification for clean room activities.