This position will be part of the Manufacturing Logistics Team at Alder Biopharmaceuticals, supporting global clinical and commercial supply and logistics operations to meet strategic business objectives. This individual will work closely with internal and external cross-functional teams to develop, implement, and enhance inventory and materials management activities. The successful candidate will have demonstrated outstanding communication, interpersonal and presentation skills, as well as strong problem solving abilities. This position will be filled at a level commensurate with experience.
Specific responsibilities will include:
- Provide leadership and oversight of all inventory control, strategic project management, system and new product integration, process excellence, and the development and use of key performance metrics and decision tools to optimize performance, efficiency, and utilization.
- Gather and analyze data to develop strategic insights and recommendations on key transportation, distribution and process change initiatives.
- Develop, implement and manage proper inventory control procedures and processes according to cGMPs to ensure inventory accuracy.
- Maintain materials inventory records and databases, track and report inventory movements, manage returns and if necessary, material destruction according to cGMPs. Participate in deviation and CAPA identification and resolution.
- Provide oversight and coordination of physical inventories at third party CMOs and storage depots.
- Consistently produce a high level of documentation accuracy and clarity according to cGMP documentation practices (GDP)
- Comply with Good Distribution Practices and cGMP practices and regulations such as FDA 21 CFR Parts 210-211 and European GMPs for medicinal products.
- Work with other team members to prepare and communicate forecasts, plans, and inventory reports to management and other internal stakeholders.
- Ensure all planning and fulfillment is managed within the contract supply terms for each third party CMO.
- Design and track metrics/KPIs for each external supplier.
- Maintain awareness of industry trends and standards by participating in benchmarking activities, and industry conferences, and integrate knowledge into development of metrics, analytics, new technology and process improvements.
- Provide strong customer service to internal and external customers
- Work with Management to manage supply risk mitigation activities and management of forward coverage/safety stock. Identify and provide options for resolving supply issues in conjunction with stakeholders.
- BS/BA degree in a science, engineering, or business field, plus a minimum of 5 years of inventory / material management experience.
- Recent experience in the pharmaceutical industry and international supply chain expertise is required. This should include experience in time-critical and temperature-sensitive transport of medicinal product.
- APICS certification CPIM/CSCP preferred.
- Excellent written and oral communication skills are essential.
- Appropriate understanding and demonstrated experience in a regulated manufacturing and supply chain setting including understanding of Good Manufacturing and Good Distribution Practices.
- Strong knowledge and understanding of pharmaceutical supply chain, material management, and international distribution experience (pharmaceuticals) preferable.
- Experience in an FDA regulated atmosphere.
- Experience implementing and working with an integrated enterprise level planning system is strongly preferred. (SAP, Oracle etc.).
To apply, please send your resume and cover letter to firstname.lastname@example.org. Please reference job code P17-02 and let us know how you heard about the opportunity.
This temporary role will be responsible for all aspects of accounts payable principally the validation, processing and filing of invoices.
Specific responsibilities will include:
- Print invoice from A/P mailbox; open mail
- Code and input A/P invoices
- Prioritize invoices according to payment terms
- Ensure proper documentation and approval prior to payment of invoices
- Check runs one week prior to due date
- Prepare and print hot checks when requested
- Research and resolve vendor inquiries
- Reconcile vendor statements, research and resolve discrepancies
- Respond to al vendor and internal inquiries
- Assist accounting department with other tasks and projects as needed
- Filing of paid invoices
- Support auditor requests to pull documentation
- High school diploma or equivalent
- Ability to be both fast and accurate in a high volume setting
- Ability to learn and follow procedures quickly
- Excellent organizational skills
- Strong interpersonal communication skills, both verbal and written
- Customer service oriented
- Experience working with Coupa and Microsoft Dynamics AX desirable
- Knowledge of Microsoft office suite, particularly Excel
To apply, please send your resume and cover letter to email@example.com. Please reference job code T17-02 and let us know how you heard about the opportunity.
The newly created position of Systems and Network Administrator I will be responsible for systems and network monitoring, support, analysis, and administration; responding to outages and performing maintenance on our network, servers, backup, e-mail, and telecommunications systems. Additional responsibilities include checking and responding to incoming IT requests from employees, diagnosing and resolving technical hardware and software issues, as well as Tier II-III end-user support.
Specific responsibilities will include:
- Active Directory users, groups, computers and group policies
- File server shares and NTFS permissions
- Network, server, hardening and change control documentation
- Server room and network closet cabling
- On-site VOIP phone system
- Exchange mailboxes and distribution lists
- Operating system patching
- Endpoint security- antivirus and IPS
- Server and workstation backup/restore including tape rotation and offsite storage
- Switch port provisioning- VLAN tagging, POE, QoS
- Security infrastructure- Firewall, spam filter, VPN
- Virtualization and storage- ESXi, vCenter, Netapp, iSCSI
- Systems and networking monitoring
- Rack and stack
- Follow and enforce security compliance standards and Company policies
- Participate in on-call rotation
- Other duties as needed
- Minimum 2 years of experience in a systems and network administration role to include experience with:
- Active Directory, Windows Server 2008/2012 operating systems
- VMWare vSphere or other enterprise-class server virtualization technology
- TCP/IP, VLANs, VPN, routing
- Cisco hardware and IOS, ASA, access switches
- One or more of the following: MS Exchange, MS SQL, MS SharePoint
- Ability to lift and carry computer equipment and peripherals up to 40 pounds
- Ability to stoop and kneel as needed to install and troubleshoot equipment
- Outstanding troubleshooting and customer service skills, with strong attention to detail
- Ability to communicate effectively in person and in writing, and project a professional image
- Ability to work with a minimum of direction, prioritize and manage own time, and proactive in keeping management informed of issues
- Patient and effective working with diverse groups of people at all levels of the organization
- Strong work ethic that includes neatness, punctuality, persistence and a positive attitude
- Experience with:
- Powershell or other scripting language in a server management role
- Enterprise backup solution
- automated software deployment technologies
- working in a government regulated environment (e.g. Sarbanes-Oxley, FDA)
- Office 365 administration
- Mac OSX Server or Linux operating system in an enterprise environment
To apply, please send your resume and cover letter to firstname.lastname@example.org. Please reference job code E17-03 and let us know how you heard about the opportunity.
Alder Biopharmaceuticals is seeking a highly motivated individual to join the Pharmaceutical Operations Process Engineering department. This position will be filled at a level commensurate with experience. This individual will ensure processes are robust, scalable, well characterized, and economical for commercial manufacturing. The successful candidate will interact with internal product development groups and with Alder’s network of external CMOs/contract labs. Primary responsibilities may include developing process characterization studies, analyzing data using statistical analysis, and providing reports to enable process validation for downstream processes.
In this position, you will lead a wide variety of process development activities including:
- Write protocols and reports to meet commercialization timelines
- Generate and implement design of experiments with subsequent statistical analysis of data
- Author regulatory sections for marketing authorization regulatory filings
- Perform on-site troubleshooting during process scale-up (international travel may be required).
- Interpret analytical results and write technical reports used as primary references for regulatory filings
- Represent process development on one or more internal project teams and also on CMO/external project teams to enable successful process validation
- BS or MS in a relevant scientific discipline (such as engineering, chemistry, biochemistry or analytical chemistry) and a minimum 5 years relevant experience.
- Experience commercializing and scaling-up purification, with an excellent working knowledge of GMP requirements, FDA and ICH guidelines.
- The candidate should have an in-depth understanding of unit operations used for downstream processing of monoclonal antibodies.
- Demonstrated experience with commercializing process development efforts, including independent design of protocols and developing acceptance criteria.
- Process validation experience preferred.
- Authoring of regulatory filings is a plus.
- Knowledge of statistical process control concepts is desired.
- The candidate must be willing to periodically travel to contract manufacturing sites. (Approximately 10-15%)
To apply, please send your resume and cover letter to email@example.com. Please reference job code P17-01 and let us know how you heard about this opportunity.
Alder is seeking an experienced Senior CRA to expand their growing Clinical Operations department. This person will contribute to clinical study conduct in accordance with all applicable regulations, Good Clinical Practice, and Alder Standard Operating Procedures. Approximately 25% travel is required.
Specific responsibilities will include:
- Function as Lead-CRA for Phase 2 and 3 studies, including management of the Clinical Project Team.
- Provide clinical study oversight through site management, on site and remote monitoring or co-monitoring, and review of monitoring visit reports.
- Assist in the selection and management of CRO’s and vendors employed by Alder for the conduct of clinical studies.
- Assist in the review and negotiation of site, CRO, and vendor contracts and budgets.
- Develop, review, and amend study protocols, informed consent forms, study specific plans, investigator brochures, clinical study reports, publications and other documents and forms.
- Review and clean data. Ensure smooth data flow from sites and CROs.
- Track clinical study supplies and biological samples.
- Actively participate in study and department meetings.
- Provide input on study resource requirements, study budget and timelines.
- Apply knowledge of therapeutic area and drug development to achieve efficient study execution.
- Self-motivated and highly flexible individual who is able to manage multiple tasks and priorities.
- N. or B.S. Degree in Life Sciences field required.
- 4-5 years of experience in clinical research. Experience with CNS (pain or migraine) is desired.
- Requires thorough knowledge of US drug development regulations and Good Clinical Practice. Knowledge of major foreign regulatory requirements is desired.
- Must have strong critical thinking, diplomacy, negotiation and communication skills.
- Proficient in MS Office applications such as Outlook, Word, Excel, Project and PowerPoint.
To apply, please send your resume and cover letter to firstname.lastname@example.org. Please reference job code C16-08 and let us know how you heard about this opportunity.
Alder BioPharmaceuticals is seeking a Corporate Counsel, Contracts to join its growing Legal Department. The Corporate Counsel, Contracts is an integral member of the Legal Department, reporting to the Senior Vice President & General Counsel, and is primarily responsible for coordinating all activities relating to legal contracts binding upon the Company. The Corporate Counsel, Contracts will take the lead role in drafting, reviewing and negotiating a wide array of contracts supporting all areas of the Company’s business, including G&A, Pharmaceutical Operations and R&D, and will provide related advice and counsel. The level of counseling requires a deep understanding of life sciences and general business transactions and related legal issues, as well as outstanding drafting and negotiation skills. The ideal candidate will have proven experience in effectively and collaboratively working with clinical research organizations, contract manufacturing organizations and other vendors. The Corporate Counsel, Contracts will also provide support on various corporate, commercial and securities legal matters as needed.
Specific responsibilities will include:
- Leads the drafting, review, interpretation, negotiation and execution of all routine agreements, such as confidentiality, material transfer, consulting, services, clinical trial, manufacturing, license and vendor agreements, while appropriately engaging the General Counsel for complicated terms or negotiations.
- Acts as a project manager, working with contract owners to move contract negotiations to completion, explaining key issues during negotiation process, making recommendations regarding negotiation strategy to achieve Company goals.
- Efficiently coordinates exchange of contract drafts and negotiation sessions.
- Understands the legal and business (including financial) provisions of contracts, and the implications of revisions of such terms by the counterparty, and proposes alternative language to achieve the Company’s goals, with assistance from General Counsel where necessary.
- Assures appropriate approval, signatures and documentation are obtained from the Company and counter party.
- Understands the Company’s business and uses this knowledge in order to most effectively negotiate contracts.
- Understands and addresses basic concerns and key terms typically associated with contracts in the biopharmaceutical industry, including confidentiality, material transfer, services, clinical trial, manufacturing and IP license contracts.
- Oversees management, storage, and organization of both paper and electronic versions of all contracts in the Company’s filing systems, as well as retrieval for internal Company purposes upon request according to Company policy.
- Remains apprised of contractual rights and obligations in executed active contracts, and appropriately advises management of such; provides summaries and reports of contract progress to management as requested.
- Communicates with Finance department regarding contractual financial obligations and payments as needed.
- Communicates with contract owners, and management where applicable, regarding contractual rights and obligations as needed.
- Provides assistance to the Legal Department in complicated or strategic transactions.
- BA/BS and JD with excellent law school credentials.
- Licensed to practice law in Washington State or be eligible for licensure as a registered in-house counsel is preferred.
- Minimum of 4 years of previous contracts management level experience within contracts function of a public life sciences/biotech company is required, and additional law firm experience is a plus.
- Exposure to the development of therapeutic biologics is highly desired.
- Experience with or knowledge of general corporate, corporate governance, corporate finance, securities, real estate, and/or intellectual property matters, including patents and trademarks, is a strong plus.
- Takes ownership of responsibilities, exercises sound judgment in decision making, has the necessary skills to solve problems and know when problems need to be elevated to the General Counsel.
- Able to work cross functionally and take initiative to make sure corporate policies are followed and appropriate action taken on all contracts.
- Strong strategic, critical thinking, diplomacy, and negotiation skills.
- Exceptional oral and written communication skills, including strong drafting skills, presentation capabilities, interpersonal and conflict resolution skills.
- Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with client and vendor organizations.
- Ability to communicate and negotiate effectively at all levels throughout the Company and all supported client groups.
- History of self-motivation, working independently on projects, meeting aggressive deadlines, and juggling multiple matters.
- Outstanding attention to detail.
- Able and willing to take on additional roles and functions, and eager to learn.
- High personal and business ethics.
- Ability to manage and work effectively with outside counsel.
Please send your cover letter and resume to email@example.com. When applying for this position, please reference job code E16-12 and let us know how you heard about the opportunity.
In this newly created leadership position, the Head of Biostatistics will support drug development activities and decision making encompassing Phase I-IV studies. This includes guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. Proven experience in strategic input into clinical development plans, and familiarity with regulatory standards and requirements. This position will report to the Chief Medical Officer.
Specific responsibilities will include:
- Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives
- Provide oversight of statistical and strategic content in support of regulatory interactions
- Effectively coordinate statistical endeavors with outside organizations, CROs and consultants
- Identify and implement emerging new ways of doing clinical development and new methodologies
- Participate in establishment and development of department SOPs
- Oversee vendors with respect to key performance indicators, metrics, and program level deliverables and timelines
- Maintain an active role in planning and preparation of regulatory submissions- briefing books and integrated summary documents
- Contribute to project budget/resource planning, re-forecasting, and program milestones, along with CPMs and Clinical Operations management
Ph.D. in Statistics or Applied Mathematics. 12+ years of clinical research and drug development experience. In-depth knowledge of methodologies applied in clinical trials with focus on registration and life-cycle management. Extensive experience of interactions with regulatory agencies- US and Non-US Strong analytical skills and demonstrated experience in gathering, interpreting and analyzing data in clinical research and drug development. Must be knowledgeable about FDA and EMA data standards and must be able to program in SAS. Must have strong communication and interpersonal skills. Flexible to changing priorities, detail-oriented, and works well under pressure. Must be able to communicate statistical information to people with no science background.
Please send your cover letter and resume to firstname.lastname@example.org. When applying for this position, please reference job code C16-04 and let us know how you heard about the opportunity.