Updated: May 8, 2012
Current Openings
- • Director, Business Development
- • Account Manager - NJ/NY/PA Account
- • Account Manager - Generic Accounts
- • Director, Project Management
- • Project Manager
- • Paralegal/Contracts Administrator
- • Quality Assurance Associate
- • Quality Assurance Associate - Inspector
- • Quality Assurance Associate - Inspector and Batch Record Review
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Director, Business Development
• Develop and execute business development plan to promote PII’s Services to potential pharmaceutical companies.
• Aggressively identify and qualify new business opportunities.
• Prepare proposals for new business opportunities.
• Develop and maintain positive relationships with clients and provide responsive customer service.
• Facilitate communication with clients during project execution with focus on client satisfaction and expanded business opportunities.
• Establish credibility and good working relationships with PII’s Formulation, Clinical, Analytical, Regulatory and other internal groups and provide them with business development/marketing support.
• Manage all business development activities within approved budget.
• Network within scientific, business development and product communities at all levels.
• Provide monthly updates in the form of reports and presentations to Senior management
• Minimum of five to seven years in a business development/sales management function in the pharmaceutical services, or other service related industries preferably with an existing network within client base of interest.
• Proven record of aggressive selling, successful closing and level of customer service that promotes repeat business.
• Bachelor’s degree in science, business administration plus MBA. Scientific background is a requirement.
• This position is based in Pii’s Hunt Valley, Maryland facility with up to 50% travel in the USA and Europe as required.
Account Manager - NJ/NY/PA Accounts
• Develop and execute a territory business plan to increase sales for specific existing NJ, NY, and PA accounts and territory growth in targeted, new accounts.
- • Identify key influencers in existing accounts; qualify new account leads and business opportunities.
- • Achieve monthly and annual sales goals; manage all business development activities within an approved budget.
- • Utilize and maintain SalesForce.com database for territory; existing and potential clients; including contacts, sales opportunities and post-call notes.
- • Travel to US clients and trade show events.
- • Build and maintain key relationships with existing and potential clients; network with business development and scientific personnel of all levels; attending trade show events, business seminars and entertaining existing/new clients.
- • Understand and address both business and technical needs of clients; promoting Pii’s capabilities by outlining features, benefits and services; listening to client’s needs and expectations.
- • Prepare contracts and proposals for existing and new business opportunities.
- • Establish credibility and build relationships within Pii’s organization: Project Management, Formulation, Analytical and Regulatory.
- • Present sales opportunities and key territory activities to business development team and senior management on monthly basis.
Requirements:
- • A four-year Bachelor’s degree in marketing, business administration or science.
- • A minimum of three years of sales experience as a territory sales representative or a business development role.
- • A documented track record of success, proven record of aggressive selling, successful closing and level of customer service that promotes repeat business.
- • The ability to demonstrate proven sales performance over time. Please bring ‘brag book’ of proven sales record, sales ranking, achievements and awards during interview
- • Demonstrated analytical skills; demonstrated success in persuasion, influence and negotiation skills.
- • Knowledge and experience in pharmaceutical or related life science sales would be desired.
- • An understanding of the healthcare industry, market dynamics, trends, competitors and FDA regulations preferred.
- • Must reside near Hunt Valley, Maryland (or be willing to re-locate) as this position is office based with 25% - 40% travel.
- • Strong work ethic and customer focus orientation.
- • Excellent communication, presentation and organization skills.
- • Computer skills: Word, Excel, PowerPoint, SalesForce.com, Microsoft Project preferred.
Account Manager - Generic Accounts
• Develop and execute a territory business plan to increase sales for specific existing generic accounts and territory growth in targeted, new generic accounts.
- • Identify key influencers in existing accounts; qualify new account leads and business opportunities.
- • Achieve monthly and annual sales goals; manage all business development activities within an approved budget.
- • Utilize and maintain SalesForce.com database for territory; existing and potential clients; including contacts, sales opportunities and post-call notes.
- • Travel to US clients and trade show events.
- • Build and maintain key relationships with existing and potential clients; network with business development and scientific personnel of all levels; attending trade show events, business seminars and entertaining existing/new clients.
- • Understand and address both business and technical needs of clients; promoting Pii’s capabilities by outlining features, benefits and services; listening to client’s needs and expectations.
- • Prepare contracts and proposals for existing and new business opportunities.
- • Establish credibility and build relationships within Pii’s organization: Project Management, Formulation, Analytical and Regulatory.
- • Present sales opportunities and key territory activities to business development team and senior management on monthly basis.
Requirements:
- • A four-year Bachelor’s degree in marketing, business administration or science.
- • A minimum of three years of sales experience as a territory sales representative or a business development role.
- • A documented track record of success, proven record of aggressive selling, successful closing and level of customer service that promotes repeat business.
- • The ability to demonstrate proven sales performance over time. Please bring ‘brag book’ of proven sales record, sales ranking, achievements and awards during interview
- • Demonstrated analytical skills; demonstrated success in persuasion, influence and negotiation skills.
- • Knowledge and experience in pharmaceutical or related life science sales would be desired.
- • An understanding of the generic healthcare industry, market dynamics, trends, competitors and FDA regulations preferred.
- • Must reside near Hunt Valley, Maryland (or be willing to re-locate) as this position is office based with 25% - 40% travel.
- • Strong work ethic and customer focus orientation.
- • Excellent communication, presentation and organization skills.
- • Computer skills: Word, Excel, PowerPoint, SalesForce.com, Microsoft Project preferred.
Director, Project Management
• 10-15 years experience in pharmaceutical industry with at least 5 years in Project Management.
• Varied product development background with some “hands-on” experience in pharmaceutical formulation & product
development.
• Responsible for managing a team of project managers & supporting the activities of the business managers in meeting,
project proposals & project planning.
• Must have a good record of delivery on challenging projects against tight timelines; take ownership & manage projects;
plan, execute & monitor client projects.
• MSc or PhD preferably in Pharmacy or Pharmaceutical related.
Project Manager
• 5 years experience in a customer service and project management function in the pharmaceutical services or allied industry.
• Responsible for aggressively managing and tracking client projects. Plan, organize and execute all aspects of projects to ensure clients' delivery needs are met.
• Capture subsequent additions to the original scope and relay details to Business Development Managers.
• Provide exceptional customer service. Update clients on project status, prepare and maintain project timelines, facilitate project meetings, prepare agendas and minutes, manage billing milestones and attend external client meetings as required.
• Develop and maintain positive relationships with clients and provide responsive customer service.
• Establish credibility and good working relations with Pii's formulation, clinical, analytical, regulatory and other internal groups.
• BS degree or higher (Pharmacy or Pharmaceutical related).
• Proficiency in Microsoft Office suite including Project, Excel, PowerPoint and Word.
Paralegal/Contracts Administrator
• Reporting to the Senior Vice President, monitor the legal workflow and assist in providing a full range of legal services.
• Write, review and negotiate a variety of agreements regularly entered into by the company, including legal language, in accordance with company guidelines.
- • Create, oversee and manage legal forms and files.
- • Interface with Management and outside counsel as needed.
- • Complete and maintain patent and trademark forms and files.
• College degree, paralegal certificate or equivalent work experience
- • 5+ years of paralegal and/or contracts administrator experience.
- • General knowledge of broad based substantive legal matters such as contracts, intellectual property
- • Previous experience working with biotech or pharmaceutical companies a plus.
- • Ability to prioritize and meet deadlines.
- • Mature judgment and critical thinking skills.
- • Ability to influence and be influenced in a fast paced, entrepreneurial work environment.
- • Excellent computer skills, proficient in MS Office, MS Word, Excel and PowerPoint.
- • Excellent communication skills, oral and written
• Review and approve batch record documentation and related material in accordance with SOPs and other statutory governing regulations
- • Initiate correction of errors and omissions, and assist in performing product investigations
• Assist in performing investigations involved with batch record reviews and raw materials as required.
- • Issue “Release”, “Hold”, and/or “Rejected” Status labels as required
• Initiate product “re-sampling” and finished product release “re-stickering”, as required.
- • Perform “Finished Product Review” of batch records to ensure that all “Line Clearance”, “Weighing Sheets”, “ Room and Equipment Labeling/Status Indicators, packaging components, etc are present, signed and dated, along with corresponding QA inspection paperwork.
• Ensure that any deviations, investigations, Out-of-Specifications” Reports, as they relate to the batch are identified and addressed in a timely manner.
Requirements:
• A background in cGMP compliance with the pharmaceutical, biologics and/or medical device manufacturing industry.
• Bachelor’s degree, preferable in the Life Sciences.
• Experience in writing and maintaining cGMP documentation
Quality Assurance Associate - Inspector
• Perform “Line Clearance” and “Cleaning Verification” for manufacturing and packaging operations per established SOPs and Batch/Packaging and Labeling Records’ requirements.
• Perform in-process sampling, inspections, testing, and batch record reviews during manufacturing and packaging operations as per established SOPs and • Batch/Packaging and Labeling Records’ requirements.
• Perform Acceptable Quality Level (AQL) sampling and testing as required for in –process and finished product.
• Participate in the preparation for sampling, actual submission and testing as required for in-process and finished product.
• Participate in the preparation for sampling, actual submission of samples to Quality Control (QC), and disposition of samples for cleaning verification.
• Perform inspection of cGMP and non-cGMP areas for compliance to policies and procedures as written approved.
• Perform daily systems verifications including, but not limited to, recording and reporting of magnehelic gauge data and water system data and the disposition of the systems.
• Participate in and support Annual Product Reviews.
• Submit product samples for analytical testing as required.
• Create storage systems for storage and retrieval of retain samples, as required.
• Perform investigational activities and prepare Incident Reports, Investigation Reports, and Planned Deviation Reports.
• Review quality systems, including policies and procedures, and recommend improvements affecting compliance and efficiencies.
• Engage in planning activities to provide for effective support of manufacturing and packaging operations.
Requirements:
• Bachelors Degree in life sciences or physical sciences
Ability to analyze data/information and to assess and resolve complex issues, as required.
• Good verbal and written communication skills are required.
• Ability to work and communicate with cross-functional teams.
• Ability to manage multiple priorities and re-prioritize, as required.
Quality Assurance Associate - Inspector and Batch Record Review
• Release/rejection of bulk and finished drug product.
- • Issuance of “Release” and/or “Rejection” Status Labels.
- • Maintain MFG waste and stage in reject cage.
- • Assist in development of cGMP and general training systems.
- • Verify all “Shipment Request” Forms, related documentation, and materials.
- • Maintain all raw materials and Finished retain samples.
- • Assist in investigations involved with raw materials and finished drug product.
- • Ensure that DOD is signed before staged in the reject cage.
- • Review in-coming DOR and forward to MM.
- • Review DOR already sampled by MM and file for schedule release.
- • Complete all cGMP documentation in a timely and accurate manner
- • Maintain DOR already sampled in the raw materials files/ready to be released
Requirements:
• A background in cGMP compliance within a pharmaceutical, biologics, and/or medical devise manufacturing industry.
- • Three to five years experience in a QA role in a cGMP-regulated environment.
- • Ability to analyze data/information and to assess complex problems.
- • Must have strong computer skills.
- • Ability to work in and effectively communicate with cross-functional teams.
- • Must possess the ability to train others in programs and procedures.
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Email, fax or mail resumes to:
Pharmaceutics International, Inc.
Attention: Karen Frazier
10947 Golden West Drive
Hunt Valley, MD 21031
Fax: 410-527-0526
Email: kfrazier@pharm-int.com