Drug Product Manufacturing Associate I Jobs

• Interpret raw data, organize results, generate/review reports, and communicate findings to project teams and management

• Extensive experience from Discovery, Pre-formulation, Formulation to Commercialization

• Experienced in formulation design, scale-up, tech transfers, & Quality by Design (QbD) studies.

• Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs) – highly coveted

• Experience authoring CMC sections for IND, BLA & MAA is highly sought after

Associate Director/Director - Formulations(Drug Product)

Supports the product management staff with product management role based training

Experience translating business and customer needs into functional and technical requirements

Attention to detail, superior time management

Work directly with user experience design, engineering, operations, sales, product marketing, and external vendors to take products from inception to delivery

Completes operational requirements as assigned within Product Department

Articulate and manage the factors that drive brand and product demand while ensuring products are delivering expected value to clients

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

CMC development experience in protein formulation, drug delivery, or analytical functions is preferred

Prior experience with drug product manufacture processes and lyophilization is a plus

Execute formulation composition and drug product process development studies for sterile liquids, lyophilized, and pre-filled dosage forms

Manufacture drug product formulation batches for evaluating formulation stability and/or to support animal studies

Conduct clinical in-use studies to guide dose solution administration

Assist in production planning, inventory management and material ordering

Under supervision, assume responsibilities for accuracy, quality, and timeliness of formulation results

Maintain records and the clean room environment to comply with safety requirements, good manufacturing practices and standard operating procedures

Strong technical skills, including a working and understanding of molecular biology and biochemistry

Demonstrated analytical, troubleshooting, math, and problem-solving skills

Demonstrated attention to detail and strong written and verbal communication skills

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

0-2 years of cGMP experience

Excellent oral and written communication skills

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.

Creates and revises SOPs (standard operating procedures) and MBRs (master batch records) as appropriate

SLED offers an exceptional benefits package for FTE positions that includes:

Maintain certification as a commissioned Class III law enforcement officer as required by the SC Criminal Justice Academy.

Must have Knowledge of forensic laboratory techniques.

Employee must be capable of completing the training for certification within one year of employment.

Maintain responsibility/security for all evidence in his/her custody. Maintain/verify all chain of custody records and coordinate the return/destruction of assigned evidence.

Follow all applicable quality assurance and safety procedures. Assist with laboratory accreditation related functions. Perform other related duties as assigned.

SLED offers an exceptional benefits package for FTE positions that includes:

Maintain certification as a commissioned Class III law enforcement officer as required by the SC Criminal Justice Academy.

Must have Knowledge of forensic laboratory techniques.

Employee must be capable of completing the training for certification within one year of employment.

Maintain responsibility/security for all evidence in his/her custody. Maintain/verify all chain of custody records and coordinate the return/destruction of assigned evidence.

Follow all applicable quality assurance and safety procedures. Assist with laboratory accreditation related functions. Perform other related duties as assigned.

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:

Minimum of 4 years of product management experience

Significant product management experience in a manufacturing environment

Desired Skills, Knowledge and Abilities:

Collaborates with channel management to drive product positioning for core customers via web and traditional print platforms

Manages product category strategy and P&L to achieve established revenue, margin and profit goals

Owns product lifecycle strategy for product offering

Time Management: Demonstrated ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines in a fast-paced environment

Some exposure to project management principles and methodologies, demonstrating an ability to manage tasks and deliver results within given timelines

Basic knowledge or experience with customer support tools, ticketing systems, or CRM software is a plus

Passion for Customer Satisfaction: A strong desire to understand customer needs and contribute to enhancing their support experience

Analytical Skills: Ability to analyze data and draw meaningful conclusions to support decision-making (Mid-level proficiency in SQL required)

$75 Monthly Flexible Wellness Benefit

Confirm equipment qualification as a part of the process validation process (e.g. correct installation, efficient operation, robust performance).

15+ years of industry experience

Serving as a technical/scientific Subject Matter Expert drug product fill & finish activities.

Overseeing that all processes are cGMP compliant and are designed to meet the regulations of the U.S FDA and the EMEA.

Ensure quality and integrity of small scale batches for clinical trials, to large scale batches for commercial production

Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teams.

Prior management and mentorship experience; passion for people management and development

Minimum of 10 years (PhD), 14 years (MS), 16 years (BS) industry experience in biopharmaceutical development

Experience in managing development teams and serving on or leading such teams comprising membership from various functional areas

Experience in parenteral Drug Product development and commercialization, including working closely with external CDMOs.

Family care benefits, including subsidized back-up care options and on-demand tutoring

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

Conduct thorough research and analysis to understand user requirements and pain points related to player account management.

Recommend innovative solutions and features that differentiate our player account management offering and drive customer satisfaction.

2+ years of experience in product management or related roles, preferably in the online sports betting or iGaming industry.

Contribute to the development and execution of the product strategy for player account management, aligning with business goals and customer needs.

Collaborate closely with Engineering teams to ensure the successful development, testing, and delivery of player account management features and enhancements.

Partner with UX/UI Designers to create intuitive and user-friendly account management interfaces, optimizing the user journey and driving customer satisfaction.

Liaise with various partners like the CMS team and Editorial as required on new capabilities

Gather requirements to define minimum viable product and phasing

Experience writing product specifications for development teams

BA/BS in Computer Science, engineering, related disciplines or equivalent practical experience

a Snapshot Of Your Responsibilities

Work effectively with a team of developers to ensure a consistently smooth process of code deployment to market

Relevant Experience: 0 – 2 years post Master’s Degree or 0 – 4 years post Bachelor’s Degree.

Exceptional laboratory skills with ability to work efficiently and productively in a highly dynamic environment

Knowledge of statistical design of experiments (DoE) and analysis

Knowledge of nucleic acid chemistry and biology is a plus

Preferred: Experience in BioPharma, BioPharmaceutical, Pharmaceutical, or Biotechnology industry

Preferred: Experience with nanoparticle formulation technology

5+ years of experience in product management with a record of successfully delivering complex products and services

Communicate with management and product stakeholders to show product features

Work with support teams to understand solution architecture, operational impacts, and ensure that solutions meet stakeholder requirements

Bachelor’s degree in computer science, business, a related field, or equivalent work experience

Extensive experience with Agile methodologies including Scrum and Kanban

Advanced knowledge of bank operations and financial solutions

Support required risk assessments and document through appropriate risk management systems

Contribute to combination product technical documentation including design history file documents, design input requirements, test plans/protocol/reports, engineering assessments, and design outputs

Relevant Experience: 0 – 2 years post Master’s degree or 0 – 4 years post Bachelor’s degree.

Exceptional laboratory skills with ability to work efficiently and productively in a highly dynamic environment

Knowledge of statistical design of experiments (DoE) and analysis

Preferred: Experience in Biopharmaceutical, Pharmaceutical, or Biotechnology industry

Participate in Drug Product teams responsible for Drug Product formulation and process development for pipeline and lifecycle management projects

Exceptional laboratory skills and demonstrated knowledge in fill/finish unit operation characterization and scale up

Experience in clinical or commercial Drug Product (or related) GMP technology transfer and validation would be a plus.

Knowledge of GMP and GLP compliance

Family care benefits, including subsidized back-up care options and on-demand tutoring

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

Strong stakeholder management and leadership skills

Experience in leading teams and/or influencing outcomes

2+ years of experience using qualitative and quantitative methodologies to understand customers ability to explore and structure customers' insights

Strong analytical and data visualization skills

Ability to translate product needs into technology requirements

Experience in payments, fin-tech, or credit building industries

Manage tech transfer activities between CMOs and/or within CMOs for scale-up of new or existing drug products.

Support process performance qualification studies and commercialization including secondary packaging.

Experience in GMP manufacturing required, along with strong understanding of US and EU regulations.

Experience working with third-party CMOs required.

Experience using statistical tools and software preferred.

Knowledge of cGMP, ICH, FDA, EMA guidelines regarding drug product supply.