Research Scientist- Formulations/Injectables

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

hermo Fishers clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

As a Research Scientist supporting the Pharm Dev Steriles in our clients Pharmaceutical R&D, you will have the opportunity to apply technical skills and expertise to develop drug product formulations and associated manufacturing processes as part of a matrix technical team. You will also use creative thinking to drive drug development of a variety of sterile product dosage forms

A Day in the Life:

Supports pre- and post-development candidates by screening and developing robust drug product compositions for a variety of traditional and non-traditional dosage forms including but not limited to nanosuspensions, hydrogels, emulsions, controlled release implants, and lyophiles.

Completes preformulation, formulation and process development activities based on established protocols and procedures.

Assists in the manufacture of batches of product as required, e.g., for process development, stability studies or clinical trials

Coordinates their activities within Pharmaceutical Development and with analytical and manufacturing representatives to meet project results

Works with the matrix technical team to align and compete preformulation, formulation and process development activities including authoring or supplying to manufacturing batch records

Identify and begin to interpret any problems in the execution of experimental processes and/or in results and communicates them to their supervisor

Proactively engage and seek assistance from other scientists to solve problems

Maintains cleanliness in own work area and in communal work areas

Anticipates/recognizes potential problems with equipment and/or supplies, and proposes/initiates action to solve or prevent problems

Operates equipment for which they are trained independently with due regard for GMP and Safety

Works to GMP/GLP as appropriate

Demonstrates timely & reliable recording of laboratory data in Labware and other suitable systems in accordance with company policy and legal requirements.

Performs data management tasks including recording results effectively and in compliance with departmental guidelines in a laboratory notebook or computer with minimal supervision (e.g. tabulating and graphing results)

Prepares oral or written summaries of results with interpretation for project work

Writes specific technical sections of internal and external reports with supervision

Attends regular safety training and is fully aware of safety requirements for their laboratory/working environment

Follows safe Laboratory and Manufacturing Practices

Maintains accurate and complete safety records consistent with company policy and legal requirements

Recognizes potential safety problems and takes action to rectify them

Education and Experience:

Bachelor’s degree in relevant life sciences degree AND 8 years of applicable experience OR PhD in relevant program AND 4 years of applicable experience

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

Solid understanding and knowledge of general chemistry and separation science

Technically competent in basic formulation/process development techniques

Demonstrates competence and experience in proper handling, recording and analyzing scientific experimental data

Has operational knowledge of routine laboratory/plant equipment

Understands the basic principles, concepts and methodology governing the work performed

Experience in development of aqueous suspensions; Practical experience in operating wet bead milling, microfluidization, homogenization equipment strongly preferred

Experience working in a GMP environment particularly for sterile products strongly preferred

Can performs literature searches independently and understands scientific literature directly related to their experiments

Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance

Ability to use Microsoft Excel and Word to perform tasks

Proficiency on technical operating systems

Proven ability in technical writing skills

Ability to work in a collaborative work environment with a team

Proven problem solving and troubleshooting abilities

Ability to train junior staff

Work Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits:

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000 colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.

This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.