Drug Product Manufacturing Associate I Jobs

An equivalent combination of education and experience may be considered

Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.

Strong planning, organization, and multitasking skills.

Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

Bachelor’s degree with 0+ years of cGMP industry experience preferred.

Biotech program certificate or equivalent and 1+ years of cGMP industry experience preferred.

High School Diploma / minimum 0+ years of relevant experience or outstanding demonstration of skills or background

Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.

Strong planning, organization, and multitasking skills.

Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.

Specific vision abilities required by this job include close vision and ability to adjust focus with tasks.

Adhere to Safety & Environmental guidelines/policies as well as cGMP and other applicable regulatory agencies.

Working knowledge and experience with lab equipment and computers

Good organization, attention to detail, basic troubleshooting aptitude, and clear technical writing skills

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

Performs hand-on operations (i.e. set-up, cleaning, solution preparation) per approved procedures and under cGMP guidelines

With guidance from senior staff, may perform and monitor critical processes

May assist in execution of routine validation and engineering protocols

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:

Operation and understanding of word processing, spreadsheets, and data management

Knowledge of GMP and safety requirements.

An equivalent of 1 – 2 years of biologics industry experience required

Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes

Knowledge of biotechnology operations such as, Aseptic Filtration Systems, Fermentation Process, Inoculation Process, Chromatography Columns, TFF step etc.

1 – 2 years of biologics industry experience required

Basic knowledge of buffer solution preparation or purification processing is preferred

Experience in single-use platform technology is preferred

Excellent written and verbal communication skills are required

Energetic, motivated and dynamic individual.

Must be organized and able to focus in a fast-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.

Manages the day to day materials, equipment, and other resource requirements to maintain Drug Product output.

Supports the management of external, technical interfaces to external manufacturing organizations.

Experience and well-developed understanding of process development approaches related to drug product.

Technical understanding and experience in biopharmaceutical process manufacturing operations and tech transfer to external organizations.

Strong interpersonal, organizational, and communication skills are required for this role.

Knowledge of GxP regulations and QbD principles are helpful.

Preferred Experience, Education & Qualifications

Provides performance management guidance to staff as needed.

Provide other assistance as needed to upper Management.

Experience working as a team member with shared responsibilities is desired.

Order equipment and perform installation, qualification, and routine maintenance.

Resolves problems of manufacturing staff and manages manufacturing resources

Knowledge in analytical method validation and knowledge of analytical method validation requirements as defined by ICH.

Experience with various analytical techniques including HPLC, Dissolution and KF. Experience with Capillary Electrophoresis is a plus.

Demonstrated problem solving skills and strong desire to grow scientifically.

Strong written and oral communication skills.

The Associate Scientist will have interdepartmental responsibilities with regards to participating in workgroups, cross-functional teams, implementation/execution, and cultural initiatives.

Development of drug product analytical methods including chromatography-based methods such as HPLC/UPLC/SEC/GC, electrophoretic-based methods such as iCIEF/CGE/CZE, LC-MS, KF and Dissolution.

Knowledge around current regulatory expectations and requirements to commercialize biopharmaceutical drug products including combination products.

Creative and motivated self-starter, with excellent verbal and written communication skills

Sound and timely decision-making and problem-solving skills in high impact situations

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

Take a lead role in drug product manufacturing process development, characterization, and tech transfer to GSK internal sites and/or external contractors.

Development of the drug product manufacturing control strategy, and authoring sections of regulatory submissions.

Basic knowledge of project management tools.

Two plus years of related product management experience.

Provides constructive, effective feedback to peers, cross-functional team members and management.

Demonstrated project management ability is required.

Recognizes values, ideas, abilities and contributions of others.

Basic presentation skills, including verbal and written communication. Basic ability to create visual presentation content.

And more benefits that come with working for a global industry leader!

5 years or more, with experience in manufacturing.

Hourly pay starting from $16.50/hr

Tuition Assistance & Employee Discounts

Must be 18 years of age

Required to work a 12 hour work schedule

Responsible for proper maintenance and operation of drug manufacturing equipment.

Accurately weighing raw materials and active ingredients and combining them into a blend.

Keeps the equipment and facility clean and in a state of good repair.

Participates in the completion of work orders, including batch record documentation per cGMP (current good manufacturing process).

Accurately follows and completes documentation with minimal errors or corrections.

Completes training, including cGMP and safety training in a timely manner.

· Experience in management of drug product production techniques and processing at CDMO sites.

Sr. Manager, Drug Product Manufacturing and CDMO Management

· Experience with sterile and aseptic drug product production in vials, pre-filled syringes, and combination drug product.

· Strong knowledge and demonstrated practice of ICH/cGXP Guidelines and regulatory submissions.

· Propose regulatory strategies for pre- and post-approval changes to manufacturing processes.

· Assist in review, implementation, and documentation of change control activities internally and at CDMOs.

Experience in technical/process development and process/technology transfer as well as GMP manufacturing operations.

Experience interacting with CMOs and managing production activities.

Technical understanding of biopharmaceutical production, with experience in cell and gene therapy.

Knowledge of aseptic processing and manufacturing.

Excellent communication skills and ability to influence across multiple functions.

Working with the manufacturing operations team to support GMP production at CMOs.

Troubleshoots manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of management.

Minimum of two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions, previous biopharmaceutical experience preferred

Detail oriented with strong written and verbal communication skills.

Familiarity with cGMP, manufacturing, machine operations, and data entry.

Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility.

Assists technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment.

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:

Proactively works with senior associates, subject matter experts, and management to achieve training competency in production operations

Required 0-2 years related experience

Good organizational and communication skills, both written and verbal, and the ability to prioritize competing tasks

Utilizes standard operating procedures and documents cGMP activities within batch records and logbooks applying good cGMP documentation and data integrity practices

Completes setup, use, and cleaning (as necessary) of cGMP production equipment

Ensures work executed in compliance with company and regulatory quality policy and systems

Support experiments to test hypotheses based on in depth knowledge of process specialty

Assist in editing and/or reviewing standard operating procedures, technical reports and qualification/validation documentation

Bachelor’s degree or equivalent in Biochemistry, Chemistry, Engineering or a closely related field with one year of experience is required

Direct experience in protein process development function such as analytical, cell culture or protein purification

Knowledge is required in the methods of one or more of these specialties

Knowledge of GMP and GLP regulations

Strong client management skills and negotiation skills.

Working knowledge pharmaceutical regulatory requirements and drug product manufacturing required.

Ensures adherence to SOPs and other regulatory requirements including FDA, DEA, and OSHA.

Stays current with the regulatory requirements, industry trends and emerging technologies

Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

8 years of pharmaceutical experience required; 12+ years and oral solid dosage experience preferred.