Scientist Genomic Medicine Bioanalytics Qc Jobs

Strong problem-solving skills, good attention to detail, time management skills and personal initiative.

Critically review and develop educational materials for sales and customer service teams, and hold periodic trainings.

Clinical expertise or related experience in relevant specialties is highly desirable.

Minimum of 3-5 years of healthcare experience in the pharmaceutical or biotech industry.

Prior experience as an Genomics Specialist in the introduction of a novel new clinical product is highly desired.

Applies advanced knowledge of the biotechnology, diagnostics and pharmaceutical industry.

Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management.

Oversee project management of all Data Integrity related activities with the relevant teams.

Manage multiple projects and ongoing work activities of moderate complexity within the division typically involving cross-functional representatives.

Demonstrated experience in Quality Control

Reasoning ability including strong analytical and problem solving abilities

Strong verbal and written communication skills

Experience with IR and AA instrumentation

H.P.L.C. and G.C. instrumentation experience

Catalent offers rewarding opportunities to further your career!

Cultivate and identify bacteria or other microorganisms isolated on selective and non-selective media.

Maintains cultures according to ATCC and departmental Standard Operating Procedures.

Performs identification of microorganisms using techniques such as API, Gram Stain, etc. Prepares reagents, standards, Medias, etc. needed for analysis.

Define project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders.

Manage onboarding and routine maintenance of laboratory instrumentation and systems.

Prepares and maintains SOP’s for the Laboratory directly related to assigned responsibilities.

A minimum of six (6) years of experience in the Pharmaceutical industry or relevant business experience.

A minimum of 4 years of experience with laboratory equipment onboarding and maintenance, is preferred

Opportunity to gain experience in the cutting-edge gene therapy space and help to develop critical lifesaving therapies for our clients

Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development

Broad Knowledge and Hands-on experience in HPLC, compendial analytical and microbiological methods, capillary gel electrophoresis, ELISA and plate-based assays.

Experience in method verification, qualification, validation and transfer.

Excellent effective written and verbal communication and interpersonal skills; established relationships within business lines

Applies discipline’s principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals

Demonstrated experience in Quality Control

Enters data into Laboratory Information Management System (LIMS) or laboratory reports.

Bachelor’s degree in science field with 5-7 years of experience, including 2 year GMP experience or regulated industry

Master’s degree in science field with 2-4 years of experience, including 2 year GMP experience regulated industry

PhD in science field with 3-5 years of experience, including 2 years GMP experience or other regulated industry

General laboratory equipment experience, including micropipettes

Must be able to read and understand English-written job instructions and safety requirements.

Developing knowledge and application of the Quality Management System (QMS).

Associate degree or High School + 2 years pharmaceutical experience in Chemistry or Biology or a related physical science.

Experience of providing QC testing support to at least one value stream.

Full understanding of the requirements and application of GMP principles in a laboratory environment.

Continuously looking for opportunities to learn, build skills and share learning.

We are looking for professionals with these required skills to achieve our goals:

Advanced organizational and time management skills.

Communicate effectively with management regarding task completion, roadblocks, and needs.

Help manage reagent and control qualification

Help manage method co-qualification/transfer and analyst training.

Bachelor’s degree or equivalent experience, preferably in biology, Chemistry, Microbiology, or related science

Minimum of 3 years of working experience in a cGMP regulated environment

Responsible for detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes.

Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations.

Able to create, review, and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records.

Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.

Excellent effective written and verbal communication and interpersonal skills

Laboratory experience, including Cell Culture, Bioassay, Aseptic Technique, and ELISA

Key Skills, Abilities, and Competencies

Documents\Reviews test data generated within and outside the department. Ensures testing conforms to current methods, GMP, and SOP requirements.

Perform laboratory equipment qualification, calibration and preventative maintenance program as needed. Maintain chemical and supply purchasing/inventory.

Working knowledge of protein, DNA or RNA, virus-based assays.

Experience in optimization and validation of bio-separation assays.

Prior experience working in either a clinical development or commercial cGMP environment is preferred.

Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management.

Oversee project management of all Data Integrity related activities with the relevant teams.

Manage multiple projects and ongoing work activities of moderate complexity within the division typically involving cross-functional representatives.

Reasoning ability including strong analytical and problem solving abilities

Strong verbal and written communication skills

Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.

Performs all work in compliance with cGMPs and site requirements.

Perform microbiological assays and PCR-based assays for routine testing and qualification/validation of new methods.

Trains less experienced analysts in new and existing procedures, techniques and governmental regulations.

Mentors analysts by providing technical knowledge and support in resolving technical problems.

High technical knowledge and practical application of relevant techniques – classical microbiology techniques

Experience with novel rapid microbial technologies such as PCR or rapid bioburden

Experience with a quality management system (QMS)

BS in Biochemistry, Chemistry or related field and 5 – 8 years of experience

5+ years of relevant experience in a cGMP QC laboratory or similar environment

Experience with Waters HPLC, UPLC and Beckman PA800 CE systems

Knowledge of GDPs, GMPs and DS / DP compendial assays (USP, EP, JP)

Experience with ELISA based impurity or potency methods

Maintain and develop working knowledge of contemporary computational chemistry methods and their application to discovery projects.

Demonstrated skills in the application of computer-assisted drug design using standard modeling and computational software packages

A working knowledge of medicinal chemistry and discovery

Basic programming experience in at least one scripting language (e.g., Perl, Python) or programming language (Java, C, C++)

Responsibilities will include, but are not limited to, the following

Develop and apply new approaches for designing bioactive-relevant features using multi parameter optimization methods.

Document Change Management experience, SOP Revision Management

Serves as management designee and will have limited input into the OTE colleague performance assessment process.

Trains others in the theory and practice of both laboratory techniques and quality systems including investigations, instrument qualifications, etc.

Independently writes SOPs, technical reports, project plans, instrument qualifications, etc.

Applicant must have high school diploma (or equivalent) with six years of relevant experience.

OR an associate degree with four years of experience.

Enters data into Laboratory Information Management System (LIMS) or laboratory reports.

Bachelor’s degree in science field with 3-5 years of experience, including 1 year GMP experience or regulated industry

Master’s degree in science field with 0-2 years of experience, including 1 year GMP experience

PhD in science field with 0-2 years of experience, GMP experience preferred or other regulated industry

General laboratory equipment experience, including micropipettes

Must be able to read and understand English-written job instructions and safety requirements.

Enters data into Laboratory Information Management System (LIMS) or laboratory reports.

Bachelor’s degree in science field with 5-7 years of experience, including 2 year GMP experience or regulated industry

Master’s degree in science field with 2-4 years of experience, including 2 year GMP experience regulated industry

PhD in science field with 3-5 years of experience, including 2 years GMP experience or other regulated industry

General laboratory equipment experience, including micropipettes

Must be able to read and understand English-written job instructions and safety requirements.

Experience with electronic document management systems and laboratory information management systems such as LIMS, SAP,and Trackwise strongly preferred.

Actively participate in visual management, standard work, and 5S activities in the QC

Knowledge and experience in cGMP test methods utilizing and applying compendial monographs and procedures such as USP/NF, EP, JP

Support qualification of instrumentation including coordination of vendor maintenance

Communicate potential improvements and updates to Raw Materials Manager

Scientific understanding and experience with laboratory instrumentation and techniques such as HPLC, pH, titrations, UV, and wet chemical techniques.

Experience with database use and management for sequencing and bioinformatics data

Knowledge of laboratory quality management system

Designated in Connect 700 Program for Applicants with Disabilities: Yes

Three years of professional experience working with next generation sequencing.

Experience with bioinformatics software packages or bioinformatics analysis and interpretation of sequencing results.

Experience preparing and presenting highly technical trainings and communicating scientific information to audiences of varied professions.