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Key Account Manager

P

PSC Biotech

Key Account Manager

Pomona, CA
Full Time
Paid
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  • Responsibilities

    Job Description

    PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.

    We focus on providing quality consulting services to ensure our client’s success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer’s expectations.

    WE ARE LOOKING FOR A US EXPAT CANDIDATE WHO CURRENTLY RESIDES IN SINGAPORE. THE KEY ACCOUNT MANAGER POSITION WILL COMBINE DIFFERENT SKILL SETS AND RESPONSIBILITIES. THE IDEAL CANDIDATE WILL BE WORKING AS AN ACCOUNT/PROJECT MANAGER, WHILE PERFORMING HANDS-ON CQV AND CSV ACTIVITIES. 

    RESPONSIBILITIES

    ACCOUNT MANAGEMENT

    • The Account Manager will advise and support clients in activities relating to project and personnel management.
    • Manages projects and personnel for assigned client accounts, while ensuring project success and client satisfaction.
    • Exercises project management by organizing budget, timelines, and deliverables for the project scope.
    • Delivers direct client support and provides technical and staff augmentation solutions.
    • Generates leads, qualifies prospects, and secures new business opportunities for Professional Services.
    • Develops and provides competitive intelligence on competing firms.
    • Establishes effective relationships with internal associates and external clients to grow an effective business team that contributes to Professional Service presence and business growth.
    • Collaborates with appropriate internal resources to develop comprehensive sales presentation materials tailored to respective clients.
    • Conducts formal sales presentations and follow-up calls to prospective new business accounts.
    • Ensures proposals are completed in a timely manner, provide the correct scope of work, and are profitable.
    • Maintains documentation of sales activities in CRM, in order to facilitate appropriate reporting of client contacts, notes, opportunities, and sales pipeline.

    PROJECT MANAGEMENT

    • Builds strong relationships with our accounting partners through consultative selling techniques and a collaborative sales approach.
    • Drives top line revenue growth through professional, consultative, and proactive interactions with all levels of clients, ranging from key decision makers to front line employees.
    • Acts as a billable consultant when available.
    • Ensures proposals account for items commonly overlooked such as: travel time, project management, off-site and pre-site visit hours, employee down-time, and equipment rentals, as applicable.
    • Follows-up on submitted information (i.e. inquiries, RFPs, proposals, etc.) as appropriate.
    • Works on projects as a billable resource.
    • Prepares, updates, reviews, and facilitates the review and approval of all required validation and engineering related deliverables.
    • Performs and supports execution and successful completion of validation deliverables.
    • Drafts, reviews, updates, and executes validation protocols (IQ, OQ, PQ). Create and write validation protocols, directives, SOPs, and reports as required and review for technical validity. 
    • Provide validation and technical direction to lead project team. Authors, edits, reviews and routes CQV documents such as commissioning forms, IQ, OQ, PQ protocols and summary reports, SOPs, Impact Assessments, URS, FS, DS, FATs, SATs, Validation Plans, and more.
    • Drive best practices toward continued or continuous process validation (CPV). Analyzes and modifies new and existing equipment and systems for optimization.
    • Assists with the development and maintenance of project deliverables.
    • Specifies, installs, validates, troubleshoots, and maintains equipment and systems.
    • Demonstrates good technical writing skills.
    • Maintains knowledge of cGMP regulations.
    • Participates in and conducts any or all types of the following validations: Cleaning, Process, Equipment, and Computer Systems.

    ENGINEERING/CQV/CSV

    • The Computer System Validation Engineer authors, reviews, and routes validation documentation for various GxP Systems and Software. The Computer System Validation Engineer collaborates with project stakeholders throughout the Software Development Life Cycle, to define requirements.  
    • Drafts, reviews, and routes local validation and compliance documents such as test scripts, SOPs, qualification protocols, gap assessments, risk assessments, Impact Assessments, User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Configuration Specifications, Traceability Matrices, Validation Plans, Validation Summary Reports, and Change Controls, for GxP Computerized Systems.
    • Executes protocols and documents results, deviations, and corrective actions.
    • Ensures compliance with 21 CFR Part 11, 820, and cGMP Regulations.
    • Assesses the impact of system changes through change management and change control systems.
    • Reviews, updates, and facilitates approval of the User Requirement Specifications (URS), Functional Specifications (FS), and Design Specifications (DS).
    • Reviews, updates, and facilitates approval of the traceability matrix.
    • Performs the change risk impact assessment.
    • Authors, facilitates review, incorporates comments, and facilitates approval of the Regression Testing (RT) Protocol and Test Scripts (Estimated based on 12 MFG and 2 OTC test scripts).
    • Authors, facilitates review, incorporates comments, and facilitates approval of the Operational Qualification / Performance Qualification / User Acceptance Test (OQ/PQ/UAT) Protocol and Test Scripts.
    • Facilitates the execution and performs post-execution review and approval of the IQ, RT and OQ/PQ/UAT testing.
    • Authors, facilitates review, incorporates comments, facilitates approval of the Data Migration Validation plan, protocol, and test scripts.
    • Authors, facilitates review, incorporates comments, facilitates approval of the Data Migration Mapping / Technical documents.
    • Performs pre and post-execution review and approval of the Data Migration technical (load, error, transformation verification) and business testing (data sampling and verification).
    • Authors, facilitates review, incorporates comments, facilitates approval of the test summary reports for IQ, RT and OQ/PQ/UAT and Data Migration.
    • Provides post-production support and ongoing support of validation systems post Go-Live.
    • Performs design, hands-on mechanical assembly, testing, troubleshooting, installation, startup, and field service of life sciences facilities, utilities, processes, systems, and equipment.  
    • Performs process design, technical writing, process troubleshooting, project management, as well as some shared administrative functions. 
    • Provides general project support, provides project drawing updates, performs assessments on equipment, utilities, and facilities, and generates and executes commission plans for various equipment according to cGMP Regulations.  
    • Optimizes Facilities and Utilities Systems for pharmaceutical manufacturing sites, according to cGMP regulations.  
    • Provides Engineering Support for Job Plan Assessments including GMP HVAC Systems Job Plans, Critical Utilities (WFI, Pure Steam, RO Water) Job Plans, Chamber Job Plans, Isolator/Hoods/Booths Job Plans, and general Facilities, Utilities, and Equipment Job Plans. Review change requests for impact to validation

     

    Requirements

    • BS in a science or engineering field or equivalent experience
    • 3+ years proven account management, client support, or business development in the life sciences industry. Professional Services experience highly desired.
    • 7+ years’ experience in CQV, CSV and/or Engineering for biopharmaceutical facilities, systems, and equipment, with project management experience.
    • Computer Systems Validation (CSV) experience in a GxP environment is required.
    • Outstanding people skills (really needs to be able to relate to engineers on a personal/professional level
    • Judgement, initiative, concern for excellence, providing direction, technical skill & competence, teamwork & Problem analysis, driving the business
    • Experience with developing user requirements, design specifications, risk assessments, validation requirements, development of protocols and plans, and overall experience with the validation life-cycle is preferred.
    • Experience with bio-pharma operations, manufacturing, engineering, and processes is required.
    • Excellent oral and written communication skills in English and local language.
    • Able to work in the US without sponsorship now or any time or in the future.
    • Demonstrated experience in developing and closing new business opportunities in the life sciences industry.
    • Proven ability to generate a high volume / high quality business opportunity in the life sciences industry.
    • Proven record of delivering high quality presentations and business proposals / contracts under tight timelines.
    • Highly organized in planning and time management, with the ability to multi-task.
    • This job description is not all-inclusive and you may be asked to do other duties.