Qc Incoming Associate Scientist Jobs

• Identify and implement manufacturing procedures intended to optimize existing processes and ensure compliance with regulatory requirements.

• Experience in flow assays a MUST

• Experience in bioassays is a plus

Introductory Experience in the use of scientific laboratory techniques, equipment and materials:

• Excellent documentation and communication skills.

• Consistent, dependable, and accurate in carrying out responsibilities

Education or experience in microbiology, math, and chemistry

Experience with GMP and GLP requirements

Experience testing natural products and ingredients

Experience with environmental and allergen testing

Experience using laboratory equipment and documentation systems

Experience writing reports and communicating results

Exercise and build basic team effectiveness skills, such as commitment, feedback and consensus management, within the work group.

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

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

Experience leading continuous improvement projects is a plus.

Perform method qualification/optimization of methods as per appropriate protocols.

Knowledge of LabWare LIMS and/or other QC data systems.

Detail-oriented with expertise in problem solving and solid decision making abilities.

Strong interpersonal skills which include a professional demeanor when interacting with Novartis personnel

Strong written and verbal communication skills are essential

Perform Bio-Analytical testing such as Flow, ELISA, cell count, cell viability, endotoxin and mycoplasma.

Learn new skills and enjoy new experiences in an engaging and safe environment

Communicates issues or challenges to senior staff and/or management

learn new skills and enjoy new experiences in an engaging and safe environment

Able to apply prior knowledge to accurately interpret structural data.

Participates in experimental design, including development of methods and testing requirements to demonstrate method suitability.

Assists with writings standard operating procedures (SOPs), methods, qualification protocols and other standard documents as directed

Desired Skills, Experience and Abilities

Perform testing using a portion of the existing laboratory assays

Perform testing using a significant portion of the existing laboratory assays

Maintains laboratory reagents, supplies and calibrated equipment

Communicates schedule, test status and concerns

Write Laboratory Investigations, as needed.

• Advance technical writing skills and ability to effectively communicate with peers and department management.

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

• May train on additional test methods and provide support to a broader spectrum of testing responsibilities.

• Demonstrated experience with basic laboratory techniques and laboratory safety practices.

• Knowledge of regulatory standards as they apply to GMP laboratories is preferred.

• Experience with LIMS and ELN computer applications is preferred.

o Assist with inventory management:

o Maintain all qualification and validation requirements for entering ISO classified area.

o Perform radiation safety duties according to SOFIE’s Corporate Radiation Compliance Program and site licensing requirements.

o Technical experience with computer-controlled automation preferred.

o Perform FDG and NaF synthesis according to SOFIE Standard Operating Procedures (SOPs):

o Ensure all materials/reagents are accepted according to SOPs and within expiry

Bachelors in Life Sciences, Engineering, Biochemistry, Biology or related field with 6+ years of relevant industry experience.

Master’s or Ph.D. with 3+ years of relevant industry experience.

Excellent knowledge and understanding of NGS, preferably with Illumina MiSeq system.

Excellent understanding of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive molecular biology.

Excellent problem-solving skills and logical approach to solving scientific problems utilizing QbD principles.

Skilled technical writer, able to convey complex topics through text and diagrams.

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

1+ years of relevant experience within a laboratory setting.

Equivalent experience working in a cGMP environment preferred

Knowledge of GMP regulations in cGMP manufacturing environment preferred.

Excellent problem solving and critical thinking skills

Excellent organization and planning skills.

Medical, Dental, & Vision benefits-effective Day 1

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.

Develop advanced knowledge in cGMP, CFR and other regulations in order to assure laboratory compliance.

Assist in critical reagent qualification/re-qualification, in compendia methods and other analytical method qualification/validation/transfer.

1+ years industrial experience in biopharmaceutical industry, such as Microbiology, Biology, or related field experience

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

Conduct routine non-compendial, biochemistry, analytical testing for in-process, release, and stability drug product samples per SOP.

Analytical methods include HPLC, Capillary Electrophoresis, SoloVPE and others.

Interpret data and make recommendations and reach decisions based on data and management input.

Determine environmental monitoring locations and qualification requirements for aseptic facility modifications and new facilities.

Review and approval of environmental monitoring data and approval of data in Laboratory Information Management System for lot release.

Demonstrated experience in industrial and/or aseptic pharmaceutical production environment, technical knowledge of aseptic processing and sanitization

Basic computer skills, such as data entry, with a high level of attention to detail, are also required

Excellent effective written and verbal communication and interpersonal skills

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:

1+ years of relevant experience within a laboratory setting.

Equivalent experience working in a cGMP environment preferred

Knowledge of GMP regulations in cGMP manufacturing environment preferred.

Excellent problem solving and critical thinking skills

Excellent organization and planning skills.

Medical, Dental, & Vision benefits-effective Day 1

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

Advance technical writing skills and ability to effectively communicate with peers and department management

0-3+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in regulated environment

0-3 years experience in Biopharmaceutical field

Experience with basic laboratory techniques and laboratory safety practices

Knowledge of regulatory standards as they apply to GMP laboratories is preferred

Experience with LIMS and ELN computer applications is preferred