Molecular Manufacturing And Operations Associate Jobs

Responsibilities also include analytical equipment procurement/qualifications, preparation and maintenance of SOP’s, determination, and control of critical reagents for example.

Collaborate with clinical operations and sample management to define sample journey and develop appropriate laboratory manuals.

Knowledge of GcLP requirements and understanding of current industry trends and regulatory expectations associated with analytical science.

A BA/BS in biological science field and a minimum of 5 years of industry Biotech/pharmaceutical/CRO experience.

Experience with Ligand Binding and/or Cell Based Assays is required

Candidates with experience doing PK, ADA, or nAb assays are preferred

Proactively identify biospecimen-related issues and opportunities for continuous improvement, communicating gaps to management

Manage study-specific timelines and deliverables, order supplies, maintain equipment and perform routine operational/administrative tasks

Work with clinical study teams to retain and discard biospecimens in compliance with subject Informed consent and applicable regulatory requirements

Perform data entry and track forms, questionnaires, and other pre clinical and clinical materials

Ensure biospecimen process consistency across preclinical and clinical studies within their respective Projects and manage biospecimen logistics

Follow GLP/GcLP standards, regulatory requirements, standard operating procedures and safety practices

Develops research plans and proposals and participates in acquiring funding

Collects, analyzes, and assures validity of data

Writes progress reports; writes and publishes findings

Collaborates with internal and external colleagues

Adheres to standards for safety and hygiene and ethical conduct as defined by the University and relevant outside parties

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Excellent planning, organizational, and time management skills.

Effectively communicating your insights and plans to cross-functional team members and management.

Evaluating business processes, anticipating requirements, uncovering areas for improvement, and developing and implementing solutions.

Working closely with clients, technicians, and managerial staff.

Ensuring solutions meet business needs and requirements.

Prioritizing initiatives based on business needs and requirements.

Vacation, sick time and holidays

Volunteer time to participate within your community

Paid sabbatical after 5 years; every 3 years thereafter

Here’s What You’ll Bring to the Table:

Generous paid time off, including:

All general responsibilities for a Molecular Assembler.

High school diploma or general education degree (GED) required.

2+ years’ experience in a FDA or other regulated manufacturing, laboratory environment, cleanroom environment experience is preferred. 

Previous experience operating automated equipment and/or assembly experience is preferred.

Basic computer skills required (Word, Excel).

Must have basic math skills and be able to perform step by step arithmetic calculations.

5+ year experience managing teams of people in high volume manufacturing setting, Gigafactory

BS or MS in Business or Technical discipline and/or evidence of exceptional experience

Communicate clearly using excellent written and verbal skills

Strong organization skills with meticulous attention to detail

Fluent with common MS office programs (Word, Excel, PowerPoint) Employee Benefits

Family-building, fertility, adoption and surrogacy benefits

Working with Manufacturing Execution Manager and Quality Control, ensure all products are tested and/or delivered within stated lead times.

Good interpersonal and teamwork skills.

Written and oral communication skills including articulate in the English language.

Preferred experience in a scientific environment utilizing a centrifuge, pH meter, spectrophotometer and/or electrophoresis

Preferred educational and experiential background:

Responsible for processing raw materials