Manager Of Drug Product Manufacturing 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)

Experience in product management roles in a manufacturing setting

Convert product strategy into detailed engineering requirements for prototyping and final development, working closely with engineering teams

Prepare comprehensive product strategy documents detailing business cases, use cases, technical requirements, revenue projections, and ROI

Excellent writing, editing, presentation, and public speaking abilities

Nice to have: Proven success as a product developer in a nonmanagerial role

Ensure data integrity for the product line across all internal and external platforms

Excellent time management skills with a proven ability to meet deadlines

Works directly with Executive Management on Company strategy, budgeting and forecasting

Makes final recommendations for capital expenditure to Executive Management

Extensive experience developing solid oral dosage forms for clinical and commercial products

Experience with aseptic dosage forms and fill finish operations is desirable, but not required

Excellent verbal and written communication skills

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

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

Project management and analytical skills; strong attention to detail

Competitive Salary [about $150K] – Hybrid (work at home days) Full Benefits-World Class Corporation

program and project management skills

Implement and manage KPI's for fleet product category

6-8 years of increasing responsibility in a product development or engineering role with a record of demonstrated achievement and leadership experience

Ability to read and manage product programs by P&L results

- Execute on 80/20 product management principles/mindset to support customer prioritization, reduction of transaction wastes, profitability improvement…

· BA/BS Degree in Engineering with Business/Marketing/Finance experience

· This position is eligible for our Crane Co. FLEX (hybrid position – in-office and remote) schedule program.

- Knowledge of product design and manufacturing principals

· Preferred experience in Automotive / Transportation market (ideally serving the Heavy Duty Commercial vehicle market segment)

· Superior analytical skills – high use of Excel

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.

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.

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